FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2901964
·
Received January 8, 2013
Report
- Report Number
- 3004209178-2013-00316
- Event Type
- Injury
- Date Received
- January 8, 2013
- Report Date
- December 17, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3093-28, LOT# J0555627V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE 'NO THERAPY ISSUES' BUT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE REPLACED ON (B)(6) 2012. THE REPORTER INDICATED THAT THE LEAD WAS 'COMPROMISED' WHICH WAS DIAGNOSED BY RUNNING AN IMPEDANCE CHECK ON THE CLINICIAN PROGRAMMER. THE PATIENT WAS NOTED TO BE RECEIVING NORMAL THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8783 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |