FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 3153126
·
Received June 8, 2013
Report
- Report Number
- 9614453-2013-01126
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 12, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TOCURRENT LEAKAGE IN A CERAMIC CAPACITOR.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD UNEXPECTED LONGEVITY WITH EARLY ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255998 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | D164AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR | Hospitalization| R |