FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3919654
·
Received July 8, 2014
Report
- Report Number
- 3004209178-2014-12652
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Report Date
- June 13, 2014
- 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT: PRODUCT ID 3889-28, LOT# V111056, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED HIGH IMPEDANCES WERE MEASURED. ALL PAIRS MEASURED GREATER THAN 4,000 OHMS. LESS THAN 50% THERAPY RELIEF WAS NOTED AS WELL. THE LEAD REMAINED IMPLANTED, BUT WAS ¿OUT OF SERVICE¿ A NEW LEAD WAS IMPLANTED. THE REPLACEMENT OCCURRED DURING A REPLACEMENT PROCEDURE FOR A NORMALLY DEPLETED BATTERY. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. PER MANUFACTURER¿S DEVICE REGISTRY SYSTEM, THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398113 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |