FDA Adverse Event
Malfunction
Summary report: N
PARADYM
MDR report key: 2043264
·
Received February 25, 2011
Report
- Report Number
- 1000165971-2011-00091
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 14, 2011
- Manufacturer
- SORIN C.R.M., S.R.L.
- Product Code
- MRM
- PMA / PMN Number
- P060027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FEB. 25, 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE ICD INVOLVED IN THIS REPORT WAS INTERROGATED UPON SCHEDULED F/U ON (B)(6) 2011. REPORTEDLY, THE PHYSICIAN OBSERVED THAT SEVERAL ATP THERAPIES HAVE BEEN RECORDED IN THE IMPLANT MEMORIES (IN ARRHYTHMIA AND THERAPIES HISTORY PANEL), HOWEVER, NO EPISODE WAS RECORDED IN HOLTER MEMORIES (AIDA).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | MRM | SORIN C.R.M., S.R.L. | PARADYM CRT 8750 | 2437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |