FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2760188
·
Received September 26, 2012
Report
- Report Number
- 3004209178-2012-08528
- Event Type
- Malfunction
- Date Received
- September 26, 2012
- Report Date
- August 28, 2012
- 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT # J0555063V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DEVICE HAD NOT WORKED FOR APPROXIMATELY THREE YEARS. PATIENT DID NOT FELT STIMULATION. PATIENT DID NOT SEE PHYSICIAN SINCE PREVIOUS DEVICE IN 2006. IN ADDITION, PRINTING PROBLEMS WITH CLINICIAN PROGRAMMER WERE REPORTED. IT WAS NO TELEMETRY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |