STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
This device is manufactured by MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Urinary Retention | 2 | Patient |
| 2024 | Urinary Frequency | 2 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Undesired Nerve Stimulation | 2 | Patient |
| 2024 | Peripheral Nervous Injury | 1 | Patient |
| 2024 | Paresthesia | 1 | Patient |
| 2024 | Pain | 11 | Patient |
| 2024 | Numbness | 2 | Patient |
| 2024 | Nerve Damage | 1 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Muscular Rigidity | 2 | Patient |
| 2024 | Insufficient Information | 16 | Patient |
| 2024 | Incontinence | 5 | Patient |
| 2024 | Headache | 1 | Patient |
| 2024 | Electric Shock | 10 | Patient |
| 2024 | Dysuria | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Discomfort | 4 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Cramp(s) /Muscle Spasm(s) | 2 | Patient |
| 2024 | Constipation | 1 | Patient |
| 2024 | Burning Sensation | 2 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Ambulation Difficulties | 1 | Patient |
| 2024 | Unstable | 2 | Device |
| 2024 | Unintended Collision | 4 | Device |
| 2024 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2024 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2024 | Positioning Problem | 1 | Device |
| 2024 | Patient Device Interaction Problem | 2 | Device |
| 2024 | Overheating of Device | 4 | Device |
| 2024 | Migration or Expulsion of Device | 8 | Device |
| 2024 | Malposition of Device | 1 | Device |
| 2024 | Intermittent Continuity | 1 | Device |
| 2024 | Insufficient Information | 8 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 4 | Device |
| 2024 | Failure to Interrogate | 3 | Device |
| 2024 | Failure to Deliver Energy | 9 | Device |
| 2024 | Energy Output Problem | 7 | Device |
| 2024 | Electromagnetic Interference | 4 | Device |
| 2024 | Electromagnetic Compatibility Problem | 6 | Device |
| 2024 | Display or Visual Feedback Problem | 1 | Device |
| 2024 | Delayed Charge Time | 3 | Device |
| 2024 | Data Problem | 1 | Device |
| 2024 | Communication or Transmission Problem | 8 | Device |
| 2024 | Charging Problem | 8 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Battery Problem | 18 | Device |
| 2024 | Application Program Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Weight Changes | 1 | Patient |
| 2023 | Urinary Retention | 2 | Patient |
| 2023 | Urinary Incontinence | 3 | Patient |
| 2023 | Urinary Frequency | 5 | Patient |
| 2023 | Unspecified Infection | 3 | Patient |
| 2023 | Undesired Nerve Stimulation | 4 | Patient |
| 2023 | Sleep Dysfunction | 1 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Scar Tissue | 2 | Patient |
| 2023 | Paresthesia | 1 | Patient |
| 2023 | Pain | 7 | Patient |
| 2023 | Micturition Urgency | 1 | Patient |
| 2023 | Itching Sensation | 2 | Patient |
| 2023 | Insufficient Information | 27 | Patient |
| 2023 | Inflammation | 2 | Patient |
| 2023 | Incontinence | 8 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Electric Shock | 11 | Patient |
| 2023 | Dysuria | 1 | Patient |
| 2023 | Discomfort | 6 | Patient |
| 2023 | Diarrhea | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 3 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 2 | Patient |
| 2023 | Burning Sensation | 3 | Patient |
| 2023 | Ambulation Difficulties | 1 | Patient |
| 2023 | Abdominal Distention | 1 | Patient |
| 2023 | Vibration | 1 | Device |
| 2023 | Unstable | 2 | Device |
| 2023 | Unintended Collision | 3 | Device |
| 2023 | Therapy Delivered to Incorrect Body Area | 3 | Device |
| 2023 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Patient Device Interaction Problem | 2 | Device |
| 2023 | Overheating of Device | 2 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Migration or Expulsion of Device | 13 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Malposition of Device | 3 | Device |
| 2023 | Intermittent Continuity | 4 | Device |
| 2023 | Insufficient Information | 17 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2023 | High impedance | 4 | Device |
| 2023 | Failure to Interrogate | 4 | Device |
| 2023 | Failure to Deliver Energy | 18 | Device |
| 2023 | Energy Output Problem | 7 | Device |
| 2023 | Electromagnetic Interference | 1 | Device |
| 2023 | Electromagnetic Compatibility Problem | 6 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Delayed Charge Time | 6 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Communication or Transmission Problem | 8 | Device |
| 2023 | Charging Problem | 7 | Device |
| 2023 | Break | 4 | Device |
| 2023 | Battery Problem | 21 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Application Program Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2022 | Urinary Retention | 1 | Patient |
| 2022 | Urinary Frequency | 3 | Patient |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Undesired Nerve Stimulation | 2 | Patient |
| 2022 | Scar Tissue | 1 | Patient |
| 2022 | Pain | 5 | Patient |
| 2022 | Nerve Damage | 1 | Patient |
| 2022 | Insufficient Information | 4 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Fluid Discharge | 1 | Patient |
| 2022 | Fecal Incontinence | 1 | Patient |
| 2022 | Electric Shock | 3 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Device Overstimulation of Tissue | 1 | Patient |
| 2022 | Device Embedded In Tissue or Plaque | 2 | Patient |
| 2022 | Constipation | 1 | Patient |
| 2022 | Burning Sensation | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unstable | 3 | Device |
| 2022 | Unintended Collision | 5 | Device |
| 2022 | Therapy Delivered to Incorrect Body Area | 7 | Device |
| 2022 | Positioning Problem | 4 | Device |
| 2022 | Pocket Stimulation | 2 | Device |
| 2022 | Patient Device Interaction Problem | 2 | Device |
| 2022 | Overheating of Device | 6 | Device |
| 2022 | No Device Output | 2 | Device |
| 2022 | Migration or Expulsion of Device | 13 | Device |
| 2022 | Malposition of Device | 4 | Device |
| 2022 | Intermittent Continuity | 1 | Device |
| 2022 | Insufficient Information | 22 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 15 | Device |
| 2022 | High impedance | 2 | Device |
| 2022 | Failure to Interrogate | 14 | Device |
| 2022 | Failure to Deliver Energy | 18 | Device |
| 2022 | Energy Output Problem | 8 | Device |
| 2022 | Electromagnetic Interference | 2 | Device |
| 2022 | Electromagnetic Compatibility Problem | 5 | Device |
| 2022 | Difficult to Remove | 2 | Device |
| 2022 | Delayed Charge Time | 4 | Device |
| 2022 | Data Problem | 3 | Device |
| 2022 | Communication or Transmission Problem | 24 | Device |
| 2022 | Charging Problem | 22 | Device |
| 2022 | Break | 4 | Device |
| 2022 | Battery Problem | 14 | Device |
| 2022 | Application Program Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2021 | Urinary Retention | 1 | Patient |
| 2021 | Undesired Nerve Stimulation | 1 | Patient |
| 2021 | Pain | 3 | Patient |
| 2021 | Nausea | 1 | Patient |
| 2021 | Insufficient Information | 3 | Patient |
| 2021 | Headache | 1 | Patient |
| 2021 | Fatigue | 1 | Patient |
| 2021 | Electric Shock | 4 | Patient |
| 2021 | Discomfort | 2 | Patient |
| 2021 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2021 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2021 | Burning Sensation | 1 | Patient |
| 2021 | Ambulation Difficulties | 1 | Patient |
| 2021 | Vibration | 1 | Device |
| 2021 | Use of Device Problem | 1 | Device |
| 2021 | Unstable | 2 | Device |
| 2021 | Therapy Delivered to Incorrect Body Area | 2 | Device |
| 2021 | Positioning Problem | 1 | Device |
| 2021 | Patient Device Interaction Problem | 1 | Device |
| 2021 | Overheating of Device | 1 | Device |
| 2021 | No Device Output | 1 | Device |
| 2021 | Migration or Expulsion of Device | 6 | Device |
| 2021 | Malposition of Device | 4 | Device |
| 2021 | Intermittent Continuity | 1 | Device |
| 2021 | Insufficient Information | 7 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2021 | Failure to Deliver Energy | 1 | Device |
| 2021 | Energy Output Problem | 1 | Device |
| 2021 | Electromagnetic Interference | 1 | Device |
| 2021 | Electromagnetic Compatibility Problem | 2 | Device |
| 2021 | Display or Visual Feedback Problem | 1 | Device |
| 2021 | Delayed Charge Time | 5 | Device |
| 2021 | Communication or Transmission Problem | 8 | Device |
| 2021 | Charging Problem | 9 | Device |
| 2021 | Break | 1 | Device |
| 2021 | Battery Problem | 4 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Undesired Nerve Stimulation | 1 | Patient |
| 2020 | Paralysis | 1 | Patient |
| 2020 | Pain | 2 | Patient |
| 2020 | Insufficient Information | 2 | Patient |
| 2020 | Electric Shock | 1 | Patient |
| 2020 | Discomfort | 1 | Patient |
| 2020 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2020 | Constipation | 1 | Patient |
| 2020 | Use of Device Problem | 1 | Device |
| 2020 | Unstable | 2 | Device |
| 2020 | Unintended Collision | 1 | Device |
| 2020 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2020 | Positioning Problem | 1 | Device |
| 2020 | Migration or Expulsion of Device | 1 | Device |
| 2020 | Insufficient Information | 2 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2020 | Energy Output Problem | 1 | Device |
| 2020 | Difficult to Remove | 1 | Device |
| 2020 | Delayed Charge Time | 2 | Device |
| 2020 | Communication or Transmission Problem | 1 | Device |
| 2020 | Charging Problem | 2 | Device |
| 2020 | Break | 3 | Device |
| 2019 | Peeled/Delaminated | 1 | Device |
| 2019 | Malposition of Device | 1 | Device |
| 2019 | Energy Output Problem | 1 | Device |
| 2019 | Break | 2 | Device |
| 2018 | Unintended Collision | 1 | Device |
| 2018 | Premature Discharge of Battery | 1 | Device |
| 2018 | Low Battery | 1 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2018 | High impedance | 1 | Device |
| 2018 | Failure to Interrogate | 1 | Device |
| 2018 | Failure to Deliver Energy | 2 | Device |
| 2018 | Device Operates Differently Than Expected | 2 | Device |
| 2018 | Device Fell | 1 | Device |
| 2018 | Device Displays Incorrect Message | 2 | Device |
| 2018 | Data Problem | 1 | Device |
| 2018 | Communication or Transmission Problem | 1 | Device |
| 2018 | Battery Problem | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2017 | Shelf Life Exceeded | 1 | Device |
| 2017 | Premature Discharge of Battery | 1 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2017 | Impedance Problem | 3 | Device |
| 2017 | Failure to Interrogate | 2 | Device |
| 2017 | Failure to Deliver Energy | 2 | Device |
| 2017 | Electromagnetic Interference | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 5 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Communication or Transmission Problem | 2 | Device |
| 2017 | Break | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2016 | Insufficient Information | 1 | Patient |
| 2016 | Unintended Collision | 1 | Device |
| 2016 | Unexpected Therapeutic Results | 1 | Device |
| 2016 | Pocket Stimulation | 1 | Device |
| 2016 | Intermittent Continuity | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2016 | High impedance | 2 | Device |
| 2016 | Failure to Interrogate | 1 | Device |
| 2016 | Failure to Deliver Energy | 2 | Device |
| 2016 | Electromagnetic Compatibility Problem | 1 | Device |
| 2016 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 4 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Communication or Transmission Problem | 1 | Device |
| 2016 | Break | 1 | Device |
| 2015 | Unintended Collision | 1 | Device |
| 2015 | No Device Output | 1 | Device |
| 2015 | Migration or Expulsion of Device | 1 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Intermittent Continuity | 1 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2015 | Failure to Interrogate | 1 | Device |
| 2015 | Failure to Deliver Energy | 3 | Device |
| 2015 | Device Operates Differently Than Expected | 3 | Device |
| 2015 | Communication or Transmission Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2014 | Shelf Life Exceeded | 1 | Device |
| 2014 | Low Battery | 1 | Device |
| 2014 | High impedance | 1 | Device |
| 2014 | Failure to Interrogate | 1 | Device |
| 2014 | Failure to Deliver Energy | 3 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Communication or Transmission Problem | 1 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |