FDA Adverse Event
Malfunction
Summary report: N
VIVA QUAD XT
MDR report key: 4160846
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02347
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 21, 2014
- Report Date
- July 21, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 THAT IT WAS NOT POSSIBLE TO INSERT THE COMPETITIVE LEAD INTO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DURING IMPLANT. THE PHYSICIAN ELECTED TO USE TO A DIFFERENT LEAD 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 |
|---|---|---|---|---|---|---|---|
| 640778 | VIVA QUAD XT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | DTBA2QQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR |