FDA Adverse Event
Injury
Summary report: N
OVATIO
MDR report key: 3315818
·
Received August 23, 2013
Report
- Report Number
- 9610579-2013-00070
- Event Type
- Injury
- Date Received
- August 23, 2013
- Date of Event
- July 24, 2013
- Report Date
- July 25, 2013
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DATE 08/23/2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE ICD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED: UPON INTERROGATION ON (B)(6) 2013, THE DEVICE WAS FOUND TO BE AT ERI, WHEREAS LONGEVITY ESTIMATIONS PREDICTED THAT THE ERI WOULD BE REACHED AROUND (B)(6) 2014. THE ICD WAS REPLACED ON (B)(6) 2013 AND WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413168 | OVATIO | MRM | SORIN CRM | OVATIO DR 6550 | S070123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |