FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3970419
·
Received July 31, 2014
Report
- Report Number
- 3004209178-2014-13741
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Report Date
- July 11, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT STATES THEY PUT THE NEW STIMULATOR IN AND 2 OF THE LEAD LINES WEREN¿T CONNECTED BUT 2 WERE. THE PATIENT STATES HE DIDN¿T BOTHER FIXING IT AND JUST LEFT 2 THAT WERE WORKING IN THERE. THE PATIENT STATES SHE DOESN¿T KNOW WHAT HAPPENED TO THE OTHER 2. THE PATIENT STATES THE REASON SHE NEEDS AN MRI WAS BECAUSE THERE WAS A POSSIBLE ISSUE WITH HER C-SPINE. THE PATIENT STATES THIS ISSUE WITH HER BACK WAS CAUSING HER HANDS AND LEGS TO NUMB AND SHE CAN¿T WALK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448019 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR |