INTESTINAL STIMULATOR
This device is manufactured by MEDTRONIC, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, ST JUDE MEDICAL - NEUROMODULATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Vomiting | 1 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Abdominal Pain | 1 | Patient |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Migration or Expulsion of Device | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2021 | Entrapment of Device | 1 | Device |
| 2021 | Device Operates Differently Than Expected | 1 | Device |
| 2019 | Unstable | 1 | Device |
| 2019 | Unintended Collision | 2 | Device |
| 2019 | Migration or Expulsion of Device | 3 | Device |
| 2019 | Material Erosion | 1 | Device |
| 2019 | Intermittent Continuity | 1 | Device |
| 2019 | Insufficient Information | 7 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | Impedance Problem | 1 | Device |
| 2019 | Entrapment of Device | 1 | Device |
| 2019 | Electromagnetic Compatibility Problem | 1 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Battery Problem | 4 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2018 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2018 | Patient-Device Incompatibility | 1 | Device |
| 2018 | Patient Device Interaction Problem | 2 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Migration or Expulsion of Device | 2 | Device |
| 2018 | Low Battery | 7 | Device |
| 2018 | Intermittent Continuity | 2 | Device |
| 2018 | Insufficient Information | 8 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2018 | Impedance Problem | 2 | Device |
| 2018 | High impedance | 1 | Device |
| 2018 | Failure to Deliver Energy | 3 | Device |
| 2018 | Energy Output Problem | 2 | Device |
| 2018 | Electromagnetic Compatibility Problem | 5 | Device |
| 2018 | Disconnection | 2 | Device |
| 2018 | Device Operates Differently Than Expected | 14 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Degraded | 1 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Battery Problem | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2017 | Unstable | 2 | Device |
| 2017 | Unintended Collision | 3 | Device |
| 2017 | Premature Discharge of Battery | 2 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Pocket Stimulation | 1 | Device |
| 2017 | Overheating of Device | 1 | Device |
| 2017 | Migration or Expulsion of Device | 5 | Device |
| 2017 | Microbial Contamination of Device | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Low Battery | 5 | Device |
| 2017 | Loss of Data | 1 | Device |
| 2017 | Insufficient Information | 3 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2017 | Impedance Problem | 2 | Device |
| 2017 | High impedance | 2 | Device |
| 2017 | Failure to Interrogate | 1 | Device |
| 2017 | Electromagnetic Interference | 2 | Device |
| 2017 | Electromagnetic Compatibility Problem | 5 | Device |
| 2017 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 23 | Device |
| 2017 | Device Inoperable | 1 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Defective Component | 1 | Device |
| 2017 | Computer Software Problem | 1 | Device |
| 2017 | Communication or Transmission Problem | 1 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Battery Problem | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2016 | Unstable | 2 | Device |
| 2016 | Unintended Collision | 2 | Device |
| 2016 | Therapy Delivered to Incorrect Body Area | 3 | Device |
| 2016 | Shelf Life Exceeded | 1 | Device |
| 2016 | Premature Discharge of Battery | 2 | Device |
| 2016 | Positioning Problem | 1 | Device |
| 2016 | Pocket Stimulation | 2 | Device |
| 2016 | Overheating of Device | 1 | Device |
| 2016 | Migration or Expulsion of Device | 4 | Device |
| 2016 | Material Deformation | 2 | Device |
| 2016 | Low Battery | 12 | Device |
| 2016 | Loss of Data | 1 | Device |
| 2016 | Intermittent Continuity | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 6 | Device |
| 2016 | Impedance Problem | 2 | Device |
| 2016 | High impedance | 3 | Device |
| 2016 | Failure to Interrogate | 1 | Device |
| 2016 | Failure to Deliver Energy | 6 | Device |
| 2016 | Electromagnetic Interference | 4 | Device |
| 2016 | Electromagnetic Compatibility Problem | 8 | Device |
| 2016 | Display or Visual Feedback Problem | 1 | Device |
| 2016 | Disconnection | 1 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 28 | Device |
| 2016 | Device Displays Incorrect Message | 3 | Device |
| 2016 | Data Problem | 1 | Device |
| 2016 | Communication or Transmission Problem | 1 | Device |
| 2016 | Break | 4 | Device |
| 2016 | Battery Problem | 5 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2015 | Vibration | 1 | Device |
| 2015 | Unstable | 1 | Device |
| 2015 | Unintended Collision | 1 | Device |
| 2015 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2015 | Shelf Life Exceeded | 2 | Device |
| 2015 | Premature Discharge of Battery | 2 | Device |
| 2015 | Overheating of Device | 1 | Device |
| 2015 | Migration or Expulsion of Device | 2 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Low Battery | 4 | Device |
| 2015 | Intermittent Continuity | 1 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 5 | Device |
| 2015 | Impedance Problem | 1 | Device |
| 2015 | High impedance | 2 | Device |
| 2015 | Failure to Deliver Energy | 1 | Device |
| 2015 | Electromagnetic Compatibility Problem | 1 | Device |
| 2015 | Display or Visual Feedback Problem | 1 | Device |
| 2015 | Disconnection | 1 | Device |
| 2015 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 12 | Device |
| 2015 | Device Displays Incorrect Message | 1 | Device |
| 2015 | Break | 2 | Device |
| 2015 | Battery Problem | 4 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2014 | Unstable | 4 | Device |
| 2014 | Unintended Collision | 5 | Device |
| 2014 | Unexpected Therapeutic Results | 1 | Device |
| 2014 | Unable to Obtain Readings | 1 | Device |
| 2014 | Shelf Life Exceeded | 1 | Device |
| 2014 | Premature Discharge of Battery | 6 | Device |
| 2014 | Pocket Stimulation | 1 | Device |
| 2014 | Overheating of Device | 3 | Device |
| 2014 | Noise, Audible | 1 | Device |
| 2014 | Migration or Expulsion of Device | 10 | Device |
| 2014 | Material Deformation | 2 | Device |
| 2014 | Malposition of Device | 4 | Device |
| 2014 | Low impedance | 2 | Device |
| 2014 | Low Battery | 7 | Device |
| 2014 | Intermittent Continuity | 4 | Device |
| 2014 | Insufficient Information | 2 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 27 | Device |
| 2014 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2014 | Impedance Problem | 1 | Device |
| 2014 | High impedance | 6 | Device |
| 2014 | Grounding Malfunction | 1 | Device |
| 2014 | Failure to Interrogate | 5 | Device |
| 2014 | Failure to Deliver Energy | 7 | Device |
| 2014 | Environmental Compatibility Problem | 1 | Device |
| 2014 | Entrapment of Device | 1 | Device |
| 2014 | Energy Output Problem | 1 | Device |
| 2014 | Electromagnetic Interference | 4 | Device |
| 2014 | Electromagnetic Compatibility Problem | 8 | Device |
| 2014 | Disconnection | 1 | Device |
| 2014 | Device Or Device Fragments Location Unknown | 2 | Device |
| 2014 | Device Operates Differently Than Expected | 38 | Device |
| 2014 | Device Displays Incorrect Message | 1 | Device |
| 2014 | Communication or Transmission Problem | 5 | Device |
| 2014 | Break | 4 | Device |
| 2014 | Battery Problem | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 37 | Device |
| 2013 | Unintended Collision | 1 | Device |
| 2013 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2013 | Shelf Life Exceeded | 1 | Device |
| 2013 | Premature Discharge of Battery | 1 | Device |
| 2013 | Migration or Expulsion of Device | 4 | Device |
| 2013 | Malposition of Device | 2 | Device |
| 2013 | Low Battery | 6 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2013 | Impedance Problem | 1 | Device |
| 2013 | Human-Device Interface Problem | 1 | Device |
| 2013 | Failure to Interrogate | 1 | Device |
| 2013 | Failure to Deliver Energy | 1 | Device |
| 2013 | Electromagnetic Compatibility Problem | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 12 | Device |
| 2013 | Compatibility Problem | 1 | Device |
| 2013 | Communication or Transmission Problem | 1 | Device |
| 2013 | Break | 2 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2012 | Unexpected Therapeutic Results | 1 | Device |
| 2012 | Premature Discharge of Battery | 1 | Device |
| 2012 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2012 | Environmental Compatibility Problem | 1 | Device |
| 2012 | Electromagnetic Compatibility Problem | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2011 | Unstable | 1 | Device |
| 2011 | Insufficient Information | 1 | Device |
| 2011 | Human-Device Interface Problem | 1 | Device |
| 2011 | Device Operates Differently Than Expected | 2 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Unintended Collision | 1 | Device |
| 2010 | Migration or Expulsion of Device | 1 | Device |
| 2010 | Failure to Deliver Energy | 1 | Device |
| 2010 | Electromagnetic Compatibility Problem | 1 | Device |
| 2010 | Device Operates Differently Than Expected | 2 | Device |
| 2010 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2009 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2008 | Unintended Collision | 1 | Device |
| 2008 | Migration or Expulsion of Device | 1 | Device |
| 2008 | Device Operates Differently Than Expected | 1 | Device |
| 2007 | Malposition of Device | 1 | Device |
| 2007 | Low Battery | 1 | Device |
| 2007 | Human-Device Interface Problem | 1 | Device |
| 2007 | Device Operates Differently Than Expected | 1 | Device |
| 2005 | Insufficient Information | 1 | Device |
| 2005 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |