FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2930109
·
Received January 25, 2013
Report
- Report Number
- 6000153-2013-00002
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- NEURO - VILLALBA
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A STYLET WAS BENT AND BROKE A LEAD. THE LEAD WAS NEVER IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION WAS REPORTED. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THE HEALTH CARE PHYSICIAN STATED "THE LEAD STYLET WAS BENT AND BROKE THE LEAD." THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35694 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | NEURO - VILLALBA | 3889-28 | VA04H0Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |