FDA Adverse Event
Malfunction
Summary report: N
PROTECTA XT CRT-D
MDR report key: 2953550
·
Received February 9, 2013
Report
- Report Number
- 9614453-2013-00249
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- December 4, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P010031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 R-WAVE WAS LOW ON A REMOTE MONITORING TRANSMISSION. THE PATIENT WAS BROUGHT TO THE OFFICE, AND THE MANUAL R -WAVE WAS OKAY. 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 |
|---|---|---|---|---|---|---|---|
| 55515 | PROTECTA XT CRT-D | LWS | IPG MFG SWITZERLAND | D354TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |