FDA Adverse Event
Malfunction
Summary report: N
TBD
MDR report key: 2423353
·
Received January 20, 2012
Report
- Report Number
- 6000153-2012-00015
- Event Type
- Malfunction
- Date Received
- January 20, 2012
- Date of Event
- December 29, 2011
- Report Date
- December 29, 2011
- Manufacturer
- NEURO - VILLALBA
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF LEAD MODEL 3093-28, LOT# V840219 SHOWED THAT THE DISTAL END ELECTRODE OF THE LEAD WAS PERFORATED BY THE STYLET CAUSING A GAP IN THE WINDING. THE OUTER INSULATION WAS NOT PUNCTURED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A BROKEN LEAD # 1 WHEN THE LEAD WAS OPENED FROM THE BOX. THE LEAD #1 WAS CRACKED OR SPLIT. THE HEALTHCARE PROVIDER WOULD NOT USE THE LEAD. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. 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 | TBD | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | NEURO - VILLALBA | 3093-28 | V840219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |