FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3421529
·
Received October 21, 2013
Report
- Report Number
- 3007566237-2013-03418
- Event Type
- Malfunction
- Date Received
- October 21, 2013
- Report Date
- September 30, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3093-33, LOT# V072754, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-33, LOT# V072754, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE YEAR THE DOCTOR SAID A WIRE HAD MOVED. IT WAS ALSO NOTED THAT THE DOCTOR TOOK AN X-RAY AND SAID "ONE WIRE WAS GOING AWAY" BUT DID NOT DO ANYTHING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538825 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR |