FDA Adverse Event
Malfunction
Summary report: N
PARADYM 2
MDR report key: 3820980
·
Received May 20, 2014
Report
- Report Number
- 1000165971-2014-00285
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 18, 2014
- Report Date
- April 23, 2014
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- MRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO PARADYM RF DR MODELS APPROVED UNDER (B)(6).
Description of Event or Problem · 1
POSSIBLE MISCLASSIFICATION OF ARRHYTHMIAS REPORTEDLY LED TO THE INAPPROPRIATE DELIVERY OF THERAPIES.
Description of Event or Problem · 1
POSSIBLE MISCLASSIFICATION OF ARRHYTHMIAS REPORTEDLY LED TO THE INAPPROPRIATE DELIVERY OF THERAPIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300393 | PARADYM 2 | MRM | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | PARADYM 2 DR 8552 | 2747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |