FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1900486
·
Received October 28, 2010
Report
- Report Number
- 6000031-2010-08582
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Date of Event
- May 1, 2010
- Report Date
- May 19, 2010
- Manufacturer
- MILACA
- Product Code
- LGW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS BEING SUBMITTED LATE FOLLOWING AN INTERNAL AUDIT. FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND. THE FRONT CASE WAS REPLACED DUE TO BROKEN PLASTIC. A WORN BATTERY PRESSURE SPRING WAS REPLACED. A MISSING COVER WAS ADDED.
Description of Event or Problem · 1
THE EXTERNAL NEUROSTIMULATOR SHUT OFF FREQUENTLY AND THE PT EXPERIENCED "POWERFUL JOLTS" WHEN IT CAME ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | LGW | MILACA | 3625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |