FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 4862000
·
Received June 23, 2015
Report
- Report Number
- 3004209178-2015-12030
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Date of Event
- May 27, 2015
- Report Date
- June 2, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3889-28, LOT# VA0V1XU, IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_WRENCH_ACC, LOT# UNKNOWN; PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE INS ((B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE INS SETSCREW WAS BACKED OUT TOO FAR.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THEY COULDN¿T INSERT THE LEAD INTO THE IMPLANTABLE NEUROSTIMULATOR (INS) HEADER BLOCK. THEY TRIED WIPING THE LEAD, BUT IT WOULD NOT ADVANCE PAST A CERTAIN POINT. A SECOND INS WAS USED AND THE LEAD ADVANCED AND HAD NO TROUBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406023 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR |