FDA Adverse Event
Malfunction
Summary report: N
EVERA S DR
MDR report key: 3252005
·
Received July 29, 2013
Report
- Report Number
- 9614453-2013-01496
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- July 4, 2013
- Report Date
- July 4, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: 6935M IMPLANTABLE TACHY LEAD IMPLANTED: UNKNOWN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AT IMPLANT, WHILE TESTING IMPEDANCES THERE WAS OVERSENSING ON THE VENTRICULAR CHANNEL. THE OVERSENSING HAS NOT OCCURRED AGAIN, NO REPROGRAMMING WAS NEEDED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352443 | EVERA S DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | DDBC3D4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00013 YR |