FDA Adverse Event
Injury
Summary report: N
ENTRUST VR
MDR report key: 3202786
·
Received July 2, 2013
Report
- Report Number
- 9614453-2013-01465
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 6, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Removal / Correction Number
- Z-1172-2009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT RECEIVED INAPPROPRIATE THERAPY. IT WAS FURTHER REPORTED THE PATIENT WAS USING A ¿CIRCULATION BOOSTER¿ DEVICE AT THE TIME WHICH USES ELECTRICAL MUSCLE STIMULATION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301053 | ENTRUST VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | D154VRC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00017 YR | Life Threatening |