GENERATOR
This device is manufactured by LIVANOVA USA.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2023-05-24 | Injury | Insufficient Information, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-05-19 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-01-06 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2022-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-01 | Malfunction | None | Energy Output Problem |
| 2019-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-21 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-10 | Malfunction | None | Energy Output Problem |
| 2018-12-01 | Malfunction | None | Energy Output Problem |
| 2018-11-30 | Malfunction | None | Energy Output Problem |
| 2018-11-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-17 | Malfunction | None | Detachment of Device or Device Component |
| 2018-09-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-25 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-19 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-08 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-03 | Malfunction | None | Detachment Of Device Component |
| 2018-05-01 | Malfunction | None | Energy Output Problem |
| 2018-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-13 | Malfunction | None | High impedance |
| 2018-02-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-05 | Death | None | High impedance |
| 2018-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-23 | Malfunction | None | Detachment Of Device Component |
| 2017-09-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-07 | Malfunction | None | High impedance |
| 2017-09-01 | Malfunction | None | Detachment Of Device Component, Mechanical Problem |
| 2017-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-24 | Malfunction | None | Corroded |
| 2017-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-02 | Malfunction | None | Energy Output To Patient Tissue Incorrect |
| 2017-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-31 | Injury | None | Communication or Transmission Problem |
| 2017-05-12 | Malfunction | None | Detachment Of Device Component |
| 2017-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2017-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-18 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-03 | Injury | None | Premature Discharge of Battery, Migration or Expulsion of Device |
| 2016-11-01 | Injury | None | Insufficient Information |
| 2016-11-01 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-23 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-20 | Malfunction | None | High impedance, Appropriate Term/Code Not Available |
| 2016-09-02 | Injury | None | Unexpected Therapeutic Results |
| 2016-09-01 | Death | None | Battery Problem, Device Operates Differently Than Expected |
| 2016-08-25 | Injury | None | Unexpected Therapeutic Results |
| 2016-07-15 | Malfunction | None | Detachment of Device or Device Component |
| 2016-07-13 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-12 | Death | None | Insufficient Information |
| 2016-05-07 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-04-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-01 | Malfunction | None | Disconnection, High impedance |
| 2016-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2015-10-19 | Death | None | Premature Discharge of Battery, High impedance |
| 2015-10-01 | Injury | None | Low Battery |
| 2015-07-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-22 | Injury | None | Unexpected Therapeutic Results |
| 2015-04-21 | Malfunction | None | Improper or Incorrect Procedure or Method |
| 2015-04-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-10 | Malfunction | None | Break, Difficult to Remove, Device Inoperable |
| 2015-04-10 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-08 | Death | None | Insufficient Information |
| 2015-04-01 | Injury | None | Device Operates Differently Than Expected |
| 2015-03-25 | Injury | None | Device Inoperable |
| 2015-03-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-01-20 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2015-01-01 | Injury | None | Low Battery |
| 2014-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-08-01 | Death | None | Insufficient Information |
| 2014-07-16 | Death | None | Insufficient Information |
| 2014-06-24 | Malfunction | None | Insufficient Information |
| 2014-06-18 | Injury | None | Extrusion, Material Protrusion/Extrusion |
| 2014-06-10 | Injury | None | Battery Problem |
| 2014-05-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-23 | Death | None | Insufficient Information |
| 2014-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-20 | Injury | None | Insufficient Information |
| 2014-05-20 | Injury | None | Insufficient Information |
| 2014-05-01 | Injury | None | Insufficient Information |
| 2014-04-24 | Death | None | Insufficient Information |
| 2014-04-18 | Injury | None | Low Battery |
| 2014-03-28 | Malfunction | None | Break, High impedance, Failure to Interrogate, Battery Problem |
| 2014-03-27 | Injury | None | Insufficient Information |
| 2014-03-23 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-14 | Injury | None | Device Operates Differently Than Expected |
| 2014-03-05 | Malfunction | None | Device Inoperable, Battery Problem |
| 2014-03-01 | Injury | None | Insufficient Information |
| 2014-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-25 | Malfunction | None | High impedance |
| 2014-02-21 | Injury | None | Extrusion |
| 2014-02-14 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-12 | Injury | None | Insufficient Information |
| 2014-02-06 | Injury | None | Insufficient Information |
| 2014-02-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-01 | Injury | None | Insufficient Information |
| 2014-01-23 | Death | None | Insufficient Information |
| 2014-01-14 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-09 | Injury | None | Insufficient Information |
| 2014-01-01 | Injury | None | Insufficient Information |
| 2014-01-01 | Injury | None | Battery Problem |
| 2014-01-01 | Injury | None | Loss of Power, Battery Problem |
| 2014-01-01 | Malfunction | None | Detachment Of Device Component |
| 2014-01-01 | Injury | None | Insufficient Information |
| 2014-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-01 | Injury | None | Migration or Expulsion of Device |
| 2014-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-01 | Injury | None | Low Battery |
| 2014-01-01 | Injury | None | Battery Problem |
| 2013-12-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-16 | Injury | None | Insufficient Information |
| 2013-12-03 | Injury | None | Break |
| 2013-12-01 | Injury | None | None |
| 2013-11-25 | Injury | None | None |
| 2013-11-11 | Injury | None | None |
| 2013-11-01 | Injury | None | None |
| 2013-11-01 | Injury | None | Insufficient Information |
| 2013-11-01 | Malfunction | None | None |
| 2013-11-01 | Injury | None | Insufficient Information |
| 2013-10-30 | Injury | None | None |
| 2013-10-29 | Injury | None | Battery Problem, Device Operates Differently Than Expected |
| 2013-10-25 | Death | None | Insufficient Information |
| 2013-10-14 | Injury | None | None |
| 2013-10-14 | Malfunction | None | None |
| 2013-10-04 | Injury | None | None |
| 2013-10-01 | Malfunction | None | Use of Incorrect Control/Treatment Settings |
| 2013-10-01 | Injury | None | None |
| 2013-09-19 | Malfunction | None | None |
| 2013-09-01 | Injury | None | None |
| 2013-09-01 | Injury | None | Insufficient Information |
| 2013-08-30 | Injury | None | None |
| 2013-08-28 | Malfunction | None | None |
| 2013-08-20 | Injury | None | None |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-07 | Injury | None | None |
| 2013-08-04 | Death | None | None |
| 2013-08-02 | Malfunction | None | None |
| 2013-08-01 | Malfunction | None | None |
| 2013-08-01 | Malfunction | None | None |
| 2013-07-31 | Malfunction | None | None |
| 2013-07-31 | Injury | None | Contamination |
| 2013-07-25 | Injury | None | None |
| 2013-07-11 | Injury | None | Charging Problem |
| 2013-06-26 | Injury | None | None |
| 2013-06-19 | Injury | None | None |
| 2013-06-10 | Injury | None | None |
| 2013-06-06 | Injury | None | None |
| 2013-06-01 | Malfunction | None | High impedance |
| 2013-05-31 | Injury | None | None |
| 2013-05-29 | Injury | None | None |
| 2013-05-21 | Injury | None | None |
| 2013-05-20 | Injury | None | None |
| 2013-05-20 | Death | None | None |
| 2013-05-10 | Malfunction | None | None |
| 2013-05-03 | Malfunction | None | None |
| 2013-05-02 | Death | None | None |
| 2013-05-01 | Injury | None | None |
| 2013-05-01 | Injury | None | None |
| 2013-04-12 | Injury | None | None |
| 2013-04-11 | Injury | None | None |
| 2013-04-02 | Injury | None | None |
| 2013-04-01 | Injury | None | None |
| 2013-03-19 | Malfunction | None | None |
| 2013-03-17 | Injury | None | None |
| 2013-03-12 | Injury | None | None |
| 2013-03-07 | Death | None | None |
| 2013-03-01 | Injury | None | None |
| 2013-02-27 | Injury | None | None |
| 2013-02-14 | Malfunction | None | None |
| 2013-02-13 | Injury | None | None |
| 2013-02-04 | Injury | None | None |
| 2013-02-04 | Injury | None | None |
| 2013-02-01 | Injury | None | None |
| 2013-02-01 | Injury | None | None |
| 2013-01-22 | Death | None | None |
| 2013-01-21 | Injury | None | None |
| 2013-01-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-01-05 | Death | None | Battery Problem |
| 2013-01-04 | Injury | None | None |
| 2013-01-03 | Injury | None | None |
| 2013-01-01 | Injury | None | None |
| 2013-01-01 | Injury | None | Insufficient Information |
| 2013-01-01 | Injury | None | None |
| 2013-01-01 | Injury | None | None |
| 2013-01-01 | Injury | None | None |
| 2013-01-01 | Injury | None | None |
| 2013-01-01 | Injury | None | None |
| 2013-01-01 | Malfunction | None | None |
| 2013-01-01 | Injury | None | None |
| 2012-12-12 | Injury | None | None |
| 2012-12-04 | Injury | None | None |
| 2012-12-04 | Malfunction | None | None |
| 2012-12-03 | Injury | None | None |
| 2012-12-01 | Injury | None | None |
| 2012-11-30 | Injury | None | None |
| 2012-11-22 | Injury | None | None |
| 2012-11-20 | Malfunction | None | None |
| 2012-11-16 | Injury | None | None |
| 2012-11-16 | Death | None | None |
| 2012-11-14 | Death | None | None |
| 2012-11-12 | Injury | None | None |
| 2012-11-09 | Injury | None | None |
| 2012-11-07 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-10-22 | Malfunction | None | None |
| 2012-10-22 | Injury | None | None |
| 2012-10-15 | Injury | None | None |
| 2012-10-09 | Malfunction | None | None |
| 2012-10-09 | Injury | None | None |
| 2012-10-03 | Malfunction | None | None |
| 2012-10-02 | Injury | None | None |
| 2012-10-01 | Malfunction | None | None |
| 2012-09-29 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2012-09-26 | Injury | None | None |
| 2012-09-25 | Death | None | None |
| 2012-09-17 | Injury | None | None |
| 2012-09-10 | Malfunction | None | None |
| 2012-09-09 | Malfunction | None | None |
| 2012-09-01 | Death | None | None |
| 2012-08-31 | Injury | None | None |
| 2012-08-20 | Injury | None | None |
| 2012-08-18 | Injury | None | None |
| 2012-08-17 | Injury | None | None |
| 2012-08-16 | Malfunction | None | None |
| 2012-08-14 | Death | None | None |
| 2012-08-13 | Injury | None | None |
| 2012-08-07 | Malfunction | None | None |
| 2012-08-04 | Malfunction | None | None |
| 2012-08-02 | Injury | None | None |
| 2012-08-01 | Injury | None | None |
| 2012-07-30 | Malfunction | None | None |
| 2012-07-17 | Injury | None | None |
| 2012-07-11 | Injury | None | None |
| 2012-07-10 | Injury | None | None |
| 2012-07-09 | Malfunction | None | None |
| 2012-07-07 | Death | None | None |
| 2012-07-03 | Injury | None | None |
| 2012-07-01 | Injury | None | None |
| 2012-07-01 | Injury | None | None |
| 2012-06-29 | Injury | None | None |
| 2012-06-29 | Injury | None | None |
| 2012-06-27 | Malfunction | None | None |
| 2012-06-26 | Injury | None | None |
| 2012-06-25 | Malfunction | None | None |
| 2012-06-25 | Injury | None | None |
| 2012-06-23 | Injury | None | None |
| 2012-06-20 | Injury | None | None |
| 2012-06-20 | Injury | None | None |
| 2012-06-20 | Injury | None | None |
| 2012-06-15 | Injury | None | None |
| 2012-06-14 | Injury | None | None |
| 2012-06-10 | Death | None | None |
| 2012-06-07 | Injury | None | None |
| 2012-06-06 | Injury | None | None |
| 2012-06-05 | Injury | None | None |
| 2012-06-01 | Injury | None | None |
| 2012-06-01 | Injury | None | None |
| 2012-06-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2012-06-01 | Malfunction | None | Insufficient Information |
| 2012-05-30 | Malfunction | None | None |
| 2012-05-26 | Injury | None | None |
| 2012-05-25 | Injury | None | None |
| 2012-05-24 | Malfunction | None | None |
| 2012-05-16 | Malfunction | None | None |
| 2012-05-09 | Injury | None | None |
| 2012-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-05-08 | Injury | None | None |
| 2012-05-04 | Injury | None | None |
| 2012-05-03 | Injury | None | None |
| 2012-05-02 | Injury | None | None |
| 2012-05-02 | Injury | None | None |
| 2012-05-01 | Injury | None | None |
| 2012-04-30 | Injury | None | None |
| 2012-04-29 | Injury | None | None |
| 2012-04-25 | Malfunction | None | None |
| 2012-04-10 | Injury | None | None |
| 2012-04-09 | Injury | None | None |
| 2012-04-05 | Injury | None | None |
| 2012-04-04 | Injury | None | None |
| 2012-04-03 | Injury | None | None |
| 2012-04-03 | Injury | None | None |
| 2012-04-03 | Injury | None | None |
| 2012-04-01 | Malfunction | None | None |
| 2012-03-30 | Malfunction | None | None |
| 2012-03-28 | Death | None | None |
| 2012-03-27 | Malfunction | None | None |
| 2012-03-25 | Death | None | None |
| 2012-03-23 | Injury | None | None |
| 2012-03-15 | Injury | None | None |
| 2012-03-07 | Malfunction | None | None |
| 2012-03-01 | Injury | None | None |
| 2012-03-01 | Injury | None | None |
| 2012-03-01 | Malfunction | None | None |
| 2012-02-20 | Injury | None | None |
| 2012-02-20 | Injury | None | None |
| 2012-02-19 | Injury | None | None |
| 2012-02-14 | Death | None | None |
| 2012-01-31 | Malfunction | None | None |
| 2012-01-24 | Injury | None | None |
| 2012-01-24 | Injury | None | None |
| 2012-01-24 | Injury | None | None |
| 2012-01-17 | Injury | None | None |
| 2012-01-16 | Death | None | Insufficient Information |
| 2012-01-12 | Injury | None | None |
| 2012-01-11 | Injury | None | None |
| 2012-01-05 | Injury | None | None |
| 2012-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-01-01 | Malfunction | None | None |
| 2012-01-01 | Death | None | None |
| 2012-01-01 | Injury | None | None |
| 2011-12-22 | Injury | None | None |
| 2011-12-19 | Malfunction | None | None |
| 2011-12-15 | Injury | None | None |
| 2011-12-15 | Malfunction | None | None |
| 2011-12-14 | Injury | None | None |
| 2011-12-13 | Malfunction | None | None |
| 2011-12-13 | Malfunction | None | None |
| 2011-12-12 | Injury | None | None |
| 2011-12-02 | Injury | None | None |
| 2011-12-01 | Injury | None | None |
| 2011-11-27 | Malfunction | None | None |
| 2011-11-23 | Death | None | None |
| 2011-11-09 | Malfunction | None | None |
| 2011-11-07 | Injury | None | None |
| 2011-11-07 | Injury | None | None |
| 2011-11-04 | Injury | None | None |
| 2011-11-04 | Malfunction | None | None |
| 2011-11-02 | Malfunction | None | None |
| 2011-11-02 | Injury | None | None |
| 2011-11-01 | Injury | None | None |
| 2011-10-31 | Malfunction | None | None |
| 2011-10-24 | Malfunction | None | None |
| 2011-10-24 | Injury | None | None |
| 2011-10-23 | Injury | None | None |
| 2011-10-18 | Death | None | None |
| 2011-10-07 | Malfunction | None | None |
| 2011-10-06 | Malfunction | None | None |
| 2011-10-04 | Injury | None | None |
| 2011-10-04 | Malfunction | None | None |
| 2011-10-01 | Death | None | Insufficient Information |
| 2011-09-27 | Malfunction | None | None |
| 2011-09-19 | Malfunction | None | None |
| 2011-09-18 | Death | None | None |
| 2011-09-15 | Injury | None | None |
| 2011-09-14 | Injury | None | None |
| 2011-09-13 | Death | None | None |
| 2011-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-09-02 | Injury | None | None |
| 2011-09-01 | Injury | None | None |
| 2011-08-25 | Injury | None | None |
| 2011-08-24 | Injury | None | None |
| 2011-08-17 | Injury | None | None |
| 2011-08-12 | Malfunction | None | None |
| 2011-08-11 | Malfunction | None | None |
| 2011-08-02 | Injury | None | None |
| 2011-08-01 | Injury | None | None |
| 2011-08-01 | Malfunction | None | None |
| 2011-08-01 | Injury | None | None |
| 2011-08-01 | Malfunction | None | None |
| 2011-07-25 | Malfunction | None | None |
| 2011-07-19 | Injury | None | None |
| 2011-07-16 | Death | None | None |
| 2011-07-15 | Malfunction | None | None |
| 2011-07-13 | Injury | None | None |
| 2011-07-12 | Injury | None | None |
| 2011-07-07 | Injury | None | None |
| 2011-07-05 | Malfunction | None | None |
| 2011-07-05 | Injury | None | None |
| 2011-07-01 | Injury | None | None |
| 2011-07-01 | Injury | None | None |
| 2011-07-01 | Injury | None | None |
| 2011-07-01 | Injury | None | None |
| 2011-07-01 | Injury | None | None |
| 2011-06-30 | Injury | None | None |
| 2011-06-30 | Malfunction | None | None |
| 2011-06-22 | Injury | None | None |
| 2011-06-17 | Injury | None | None |
| 2011-06-16 | Malfunction | None | None |
| 2011-06-16 | Injury | None | None |
| 2011-06-15 | Injury | None | None |
| 2011-06-08 | Injury | None | None |
| 2011-06-08 | Injury | None | None |
| 2011-06-07 | Injury | None | None |
| 2011-06-05 | Injury | None | None |
| 2011-06-01 | Malfunction | None | None |
| 2011-06-01 | Injury | None | None |
| 2011-06-01 | Injury | None | None |
| 2011-06-01 | Injury | None | None |
| 2011-05-30 | Injury | None | None |
| 2011-05-28 | Death | None | None |
| 2011-05-27 | Injury | None | None |
| 2011-05-26 | Injury | None | None |
| 2011-05-11 | Injury | None | None |
| 2011-05-05 | Injury | None | None |
| 2011-05-03 | Injury | None | None |
| 2011-05-03 | Malfunction | None | None |
| 2011-04-26 | Injury | None | None |
| 2011-04-14 | Injury | None | None |
| 2011-04-13 | Injury | None | None |
| 2011-04-01 | Injury | None | None |
| 2011-03-31 | Malfunction | None | None |
| 2011-03-31 | Injury | None | None |
| 2011-03-31 | Injury | None | None |
| 2011-03-25 | Malfunction | None | None |
| 2011-03-23 | Injury | None | None |
| 2011-03-23 | Injury | None | None |
| 2011-03-22 | Malfunction | None | None |
| 2011-03-17 | Malfunction | None | None |
| 2011-03-09 | Malfunction | None | None |
| 2011-03-02 | Injury | None | None |
| 2011-03-01 | Injury | None | None |
| 2011-03-01 | Injury | None | None |
| 2011-02-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2011-02-24 | Injury | None | None |
| 2011-02-13 | Malfunction | None | None |
| 2011-02-09 | Injury | None | None |
| 2011-02-08 | Injury | None | None |
| 2011-02-02 | Injury | None | None |
| 2011-01-20 | Malfunction | None | None |
| 2011-01-19 | Injury | None | None |
| 2011-01-06 | Injury | None | None |
| 2011-01-06 | Injury | None | None |
| 2011-01-01 | Malfunction | None | Insufficient Information |
| 2011-01-01 | Malfunction | None | None |
| 2011-01-01 | Injury | None | None |
| 2011-01-01 | Malfunction | None | None |
| 2011-01-01 | Injury | None | None |
| 2011-01-01 | Injury | None | None |
| 2011-01-01 | Injury | None | None |
| 2011-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-01-01 | Injury | None | None |
| 2011-01-01 | Death | None | None |
| 2010-12-28 | Death | None | None |
| 2010-12-23 | Injury | None | None |
| 2010-12-15 | Injury | None | None |
| 2010-12-13 | Injury | None | None |
| 2010-12-01 | Injury | None | None |
| 2010-12-01 | Malfunction | None | None |
| 2010-12-01 | Injury | None | Insufficient Information |
| 2010-11-24 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2010-11-18 | Injury | None | None |
| 2010-11-17 | Injury | None | None |
| 2010-11-08 | Injury | None | None |
| 2010-11-02 | Injury | None | None |
| 2010-11-01 | Injury | None | None |
| 2010-10-22 | Injury | None | None |
| 2010-10-13 | Injury | None | None |
| 2010-10-12 | Malfunction | None | None |
| 2010-10-08 | Injury | None | None |
| 2010-10-05 | Injury | None | None |
| 2010-10-01 | Injury | None | None |
| 2010-10-01 | Injury | None | None |
| 2010-10-01 | Injury | None | None |
| 2010-09-30 | Malfunction | None | Premature End-of-Life Indicator |
| 2010-09-30 | Malfunction | None | Premature End-of-Life Indicator |
| 2010-09-20 | Death | None | None |
| 2010-09-18 | Injury | None | None |
| 2010-09-09 | Injury | None | None |
| 2010-09-08 | Malfunction | None | None |
| 2010-09-02 | Malfunction | None | None |
| 2010-08-27 | Injury | None | None |
| 2010-08-24 | Malfunction | None | None |
| 2010-08-23 | Injury | None | None |
| 2010-08-17 | Injury | None | None |
| 2010-08-11 | Death | None | None |
| 2010-08-05 | Malfunction | None | None |
| 2010-08-01 | Injury | None | None |
| 2010-08-01 | Injury | None | None |
| 2010-08-01 | Injury | None | None |
| 2010-07-27 | Injury | None | None |
| 2010-07-08 | Injury | None | None |
| 2010-07-07 | Injury | None | None |
| 2010-07-01 | Injury | None | None |
| 2010-06-30 | Injury | None | None |
| 2010-06-30 | Injury | None | None |
| 2010-06-11 | Injury | None | None |
| 2010-06-06 | Death | None | None |
| 2010-06-01 | Malfunction | None | None |
| 2010-06-01 | Malfunction | None | None |
| 2010-06-01 | Injury | None | None |
| 2010-05-13 | Injury | None | None |
| 2010-05-09 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2010-05-05 | Malfunction | None | None |
| 2010-05-01 | Malfunction | None | None |
| 2010-04-27 | Injury | None | None |
| 2010-04-25 | Death | None | None |
| 2010-04-06 | Malfunction | None | None |
| 2010-04-02 | Malfunction | None | None |
| 2010-04-01 | Injury | None | None |
| 2010-03-31 | Injury | None | None |
| 2010-03-31 | Injury | None | None |
| 2010-03-23 | Injury | None | None |
| 2010-03-22 | Injury | None | None |
| 2010-03-19 | Injury | None | None |
| 2010-03-10 | Injury | None | Insufficient Information |
| 2010-03-02 | Malfunction | None | None |
| 2010-03-01 | Injury | None | None |
| 2010-03-01 | Injury | None | None |
| 2010-02-23 | Injury | None | None |
| 2010-02-13 | Injury | None | None |
| 2010-02-08 | Injury | None | None |
| 2010-02-01 | Injury | None | None |
| 2010-02-01 | Injury | None | None |
| 2010-02-01 | Malfunction | None | None |
| 2010-02-01 | Injury | None | None |
| 2010-02-01 | Injury | None | None |
| 2010-01-27 | Injury | None | None |
| 2010-01-25 | Injury | None | None |
| 2010-01-17 | Injury | None | None |
| 2010-01-15 | Injury | None | None |
| 2010-01-06 | Injury | None | None |
| 2010-01-04 | Malfunction | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Malfunction | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Death | None | None |
| 2010-01-01 | Malfunction | None | None |
| 2010-01-01 | Injury | None | None |
| 2010-01-01 | Injury | None | None |
| 2009-12-01 | Injury | None | None |
| 2009-11-24 | Malfunction | None | None |
| 2009-11-11 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2009-11-01 | Malfunction | None | None |
| 2009-11-01 | Malfunction | None | None |
| 2009-10-20 | Injury | None | None |
| 2009-10-16 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2009-10-01 | Injury | None | None |
| 2009-09-21 | Injury | None | None |
| 2009-09-05 | Death | None | None |
| 2009-09-01 | Injury | None | None |
| 2009-08-20 | Malfunction | None | None |
| 2009-07-10 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2009-07-10 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2009-07-01 | Injury | None | None |
| 2009-06-19 | Injury | None | None |
| 2009-06-01 | Injury | None | None |
| 2009-04-23 | Malfunction | None | None |
| 2009-04-03 | Injury | None | None |
| 2009-03-05 | Injury | None | None |
| 2009-03-01 | Injury | None | None |
| 2009-02-09 | Injury | None | None |
| 2009-02-05 | Malfunction | None | None |
| 2009-01-01 | Malfunction | None | None |
| 2009-01-01 | Malfunction | None | None |
| 2009-01-01 | Malfunction | None | None |
| 2008-12-17 | Injury | None | Device Operates Differently Than Expected |
| 2008-10-17 | Injury | None | None |
| 2008-09-17 | Malfunction | None | None |
| 2008-08-01 | Malfunction | None | None |
| 2008-07-15 | Death | None | Insufficient Information |
| 2008-06-26 | Malfunction | None | None |
| 2008-05-01 | Injury | None | None |
| 2008-04-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2008-01-01 | Injury | None | None |
| 2007-12-21 | Death | None | None |
| 2007-12-21 | Malfunction | None | None |
| 2007-11-16 | Malfunction | None | None |
| 2007-09-16 | Malfunction | None | None |
| 2007-09-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2007-09-09 | Death | None | Insufficient Information |
| 2007-09-01 | Malfunction | None | None |
| 2007-08-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2007-07-30 | Injury | None | None |
| 2007-02-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2007-02-05 | Malfunction | None | None |
| 2007-01-22 | Injury | None | None |
| 2007-01-01 | Injury | None | None |
| 2007-01-01 | Malfunction | None | None |
| 2006-10-16 | Malfunction | None | Premature End-of-Life Indicator |
| 2006-07-15 | Death | None | None |
| 2006-07-11 | Malfunction | None | Leak/Splash, Battery Problem, Device Operates Differently Than Expected |
| 2006-07-01 | Injury | None | None |
| 2006-05-03 | Injury | None | None |
| 2006-02-24 | Injury | None | None |
| 2006-01-01 | Injury | None | Insufficient Information |
| 2006-01-01 | Injury | None | None |
| 2005-05-16 | Injury | None | None |
| 2005-05-14 | Malfunction | None | None |
| 2005-04-07 | Injury | None | None |
| 2005-02-15 | Injury | None | None |
| 2005-01-30 | Death | None | Insufficient Information |
| 2005-01-01 | Injury | None | None |
| 2005-01-01 | Malfunction | None | None |
| 2004-12-17 | Injury | None | Use of Incorrect Control/Treatment Settings |
| 2004-12-01 | Injury | None | None |
| 2004-11-15 | Injury | None | None |
| 2004-10-24 | Malfunction | None | None |
| 2004-10-07 | Malfunction | None | None |
| 2004-09-16 | Malfunction | None | None |
| 2004-08-09 | Malfunction | None | None |
| 2004-07-16 | Malfunction | None | None |
| 2004-07-13 | Malfunction | None | None |
| 2004-05-17 | Malfunction | None | None |
| 2004-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2004-03-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2004-02-26 | Injury | None | None |
| 2004-01-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2004-01-01 | Malfunction | None | None |
| 2003-12-22 | Malfunction | None | Protective Measures Problem |
| 1998-07-01 | Injury | None | None |