FDA Adverse Event
Malfunction
Summary report: N
EZW
MDR report key: 1565613
·
Received December 14, 2009
Report
- Report Number
- 3007566237-2009-09290
- Event Type
- Malfunction
- Date Received
- December 14, 2009
- Date of Event
- November 17, 2009
- Report Date
- November 17, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF STIMULATION SENSATION. IMPEDANCE MEASURED HIGH. A REVISION WAS PERFORMED AND IT WAS CONFIRMED THAT THE LEAD DID NOT GIVE EFFECTIVE STIMULATION WHEN INTERROGATED WITH THE SCREENER. THE LEAD WAS REPLACED. PT WAS REPORTED AS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZW | INTERSTIM | EZW | MEDTRONIC NEUROMODULATION | IPG URO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| LEAD: MODEL 3889, LOT# UNK| IMPLANTED: |