FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2244050
·
Received August 24, 2011
Report
- Report Number
- 3007566237-2011-06769
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 8, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH IMPEDANCE MEASUREMENTS OF >4000 OHMS WERE OBTAINED ON SOME OF THE BIPOLAR PAIRS. THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE BOTH SWITCHED OUT AND BOTH TIMES ALL COMBINATION WITH ELECTRODE 0 SHOWED >4000 OHMS. THE HCP INDICATED, HE SAW ALL CONTACTS ON HEADER BLOCK WERE BLUE. THE SECOND LEAD AND INS WERE LEFT IN PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS IMPLANTED WITH A DIFFERENT DEVICE AND WAS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC NEUROMODULATION | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LEAD: MODEL 3889, LOT# V598059| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD113653N |