FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 2850719
·
Received November 23, 2012
Report
- Report Number
- 1000165971-2012-00459
- Event Type
- Injury
- Date Received
- November 23, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 15, 2012
- Manufacturer
- SORIN CRM S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
REPORTEDLY, ONE DAY AFTER THE IMPLANTATION OF THE SUBJECT PACEMAKER INVOLVED IN THIS MDR REPORT, THE VENTRICULAR LEAD IMPEDANCE WAS MEASURED OVER 3000 OHMS. THE PHYSICIAN DECIDED TO OPERATE AT THE OPERATING ROOM. AFTER REOPENING, THE LEAD WAS FOUND CORRECTLY TIGHTENED. THE LEAD WAS THEN UNSCREWED AND TESTED: A NORMAL IMPEDANCE (692 OHMS) WAS FOUND. THE LEAD WAS THEN REINSERTED AND TIGHTENED, BUT THE VENTRICULAR IMPEDANCE REMAINED GREATER THAN 3000 OHMS. THE DEVICE WAS NOT KEPT IMPLANTED AND RETURNED OR ANALYSIS. ANOTHER PACEMAKER WAS SUCCESSFULLY IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN CRM S.R.L. | REPLY DR | 2649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |