FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 3122248
·
Received May 17, 2013
Report
- Report Number
- 1000165971-2013-00244
- Event Type
- Injury
- Date Received
- May 17, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 23, 2013
- Manufacturer
- SORIN GROUP ITALIA
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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, THE SUBJECT DEVICE WAS REPLACED DURING A LEAD RE-INTERVENTION (DUE TO HIGH LEAD IMPEDANCE) BECAUSE OF NORMAL BATTERY DEPLETION. BECAUSE THE PHYSICIAN DID NOT SUSPECT ANY MALFUNCTION, THE DEVICE WAS DISPOSED OF. HOWEVER, THE COMPANY DISTRIBUTOR REVIEWED FOLLOW UP DATA AND OBSERVED OVERSENSING. AN EXPLANATION RELATED TO THIS OVERSENSING. AN EXPLANATION RELATED TO THIS OVERSENSING PHENOMENON WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218841 | REPLY | NVZ | SORIN GROUP ITALIA | REPLY SR | 2588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |