FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1910980
·
Received November 23, 2010
Report
- Report Number
- 3004209178-2010-09911
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- August 3, 2010
- Report Date
- November 18, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
F/U INFO RECEIVED FROM THE HEALTHCARE PROFESSION INDICATED THAT THE PT HAD 2 NEUROSTIMULATOR SYSTEMS (LEFT AND RIGHT). THE PT HAD FALLEN AND DAMAGED BOTH DEVICE SYSTEMS. THE HIGH IMPEDANCES WERE MEASURED AT THE LEAD REVISION PROCEDURE. ATTEMPTS TO REPROGRAM AROUND THE DAMAGE WERE UNSUCCESSFUL. THE LEFT LEAD WAS REMOVED ENTIRELY BUT THE DEVICE WAS LEFT IN PLACE. THE DAMAGED LEAD ON THE RIGHT SIDE WAS REPLACED. IT WAS NOTED THAT THE PT HAD MANY OTHER ISSUES AND THAT THE LEVEL OF RELIEF THE PT REPORTED VARIED GREATLY. THE PT HAD A F/U APPOINTMENT WITH THE PHYSICIAN AND THE PLAN WAS TO REPLACE THE ENTIRE SYSTEM. IF ADDITIONAL INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SENT. SEE MFR REPORT # 3004209178-2010-06632.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | PROGRAMMER: MODEL 3037, LOT# NJD079824N| LEAD: MODEL 3093, LOT# V179757| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V179757| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH040853V| EXPLANTED: |