FDA Adverse Event
Malfunction
Summary report: N
PROTECTA XT CRT-D
MDR report key: 3990817
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01756
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 10, 2014
- Report Date
- June 11, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- 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 THE DEVICE WAS REPROGRAMMED DUE TO ¿INAPPROROPRIATE OPTIVOL ALERT¿. THE DEVICE REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469951 | PROTECTA XT CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D354TRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Required Intervention | 5554-53, 6935M62, 419678 LEADS |