FDA Adverse Event
Malfunction
Summary report: N
PARADYM
MDR report key: 1675914
·
Received April 23, 2010
Report
- Report Number
- 1000165971-2010-00657
- Event Type
- Malfunction
- Date Received
- April 23, 2010
- Date of Event
- April 2, 2010
- Report Date
- April 13, 2010
- Manufacturer
- SORIN BIOMEDICA C.R.M., S.R.L.
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4) - THIS EVENT CONCERNS A DEVICE THAT WAS MFR AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
UPON A FOLLOW-UP PERFORMED ON (B) (6) 2010, NO HOLTER DATA WERE RETRIEVED FROM THE IMPLANT MEMORIES (I.E. HOLTER MEMORIES - AIDA - WERE EMPTY). HOWEVER, UPON A PREVIOUS FOLLOW-UP PERFORMED ON (B) (6) 2010, 92-DAYS POST IMPLANT) NORMAL OPERATION WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | MRM | SORIN BIOMEDICA C.R.M., S.R.L. | PARADYM DR 8550 | 2396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |