FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3900736
·
Received June 27, 2014
Report
- Report Number
- 3004209178-2014-12201
- Event Type
- Malfunction
- Date Received
- June 27, 2014
- Report Date
- June 4, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28 LOT# VA03N5Q, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT HAD SOME REPROGRAMMING DONE AT THEIR HEALTHCARE PROVIDER¿S OFFICE AND SINCE THEN THEY HAD A MINOR SURGERY. IT WAS NOTED THAT SINCE SURGERY, THE PATIENT HAD A RETURN OF SYMPTOMS SINCE THE LAST WEEK AND A HALF PRIOR TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377776 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR |