FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2477951
·
Received March 5, 2012
Report
- Report Number
- 3004209178-2012-01349
- Event Type
- Malfunction
- Date Received
- March 5, 2012
- Date of Event
- February 8, 2012
- Report Date
- February 8, 2012
- Manufacturer
- MDT 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
LEAD MODEL 3093-33 LOT V863545 IMPLANTED: (B)(6) 2012 EXPLANTED: NA. PROGRAMMER MODEL 3037 (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE LEAD WAS IMPLANTED, THERE WERE OUT OF RANGE/HIGH IMPEDANCES. THE PHYSICIAN ATTEMPTED TO REINSERT THE LEAD BUT ENDED UP REPLACING IT. AFTER THE LEAD WAS REPLACED, IMPEDANCES WERE NORMAL. THE PATIENT WAS DOING WELL POST PROCEDURE. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | SEE H10 |