FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2190991
·
Received July 19, 2011
Report
- Report Number
- 3004209178-2011-05580
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 24, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED NUMBNESS IN HER LEG AFTER FAILING ON HER IMPLANTED NEUROSTIMULATOR. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT# 3004209178-2011-05581.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD094867N| EXPLANTED:| LEAD: MODEL 3093 LOT# V340507| LEAD MODEL: 3093 LOT# V340507| IMPLANTED:| EXPLANTED:| LOT# NJY137970H| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037 LOT# NJD094865N |