FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 4230317
·
Received November 6, 2014
Report
- Report Number
- 3007566237-2014-03245
- Event Type
- Injury
- Date Received
- November 6, 2014
- Report Date
- October 17, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) DID A FULL IMPLANT FOR A YOUNGER AND ACTIVE PATIENT, AND THE BATTERY ENDED UP TURNING IN THE POCKET. THE BATTERY ENDED UP BEING SIDEWAYS SO THE HCP HAD TO GO IN AND REDO THE POCKET. THE SAME THING HAPPENED AGAIN SO THEY WENT IN A THIRD TIME AND MADE THE POCKET MUCH, MUCH DEEPER. THE POCKETS WERE TIGHT AND THAT WASN'T THE PROBLEM, BUT THEY MADE THE POCKET MUCH DEEPER AND NOW THE PATIENT WAS DOING FINE. NO PATIENT INFORMATION WAS REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713706 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INTERSTIM_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |