FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 2792281
·
Received October 12, 2012
Report
- Report Number
- 1000165971-2012-00390
- Event Type
- Injury
- Date Received
- October 12, 2012
- Date of Event
- September 4, 2012
- Report Date
- October 4, 2012
- Manufacturer
- SORIN CRM S.R.L.
- 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)(6) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
ELECTRICAL ISSUES WERE REPORTED RELATIVE TO THE SUBJECT PACEMAKER. DURING A FOLLOW UP ON (B)(6) 2012 PACING FAILURE AND AN INCREASED OUTPUT WERE NOTED, ON (B)(6) 2012 THRESHOLD FLUCTUATION WAS OBSERVED. THE PACING SYSTEM WAS EXPLANTED AND REPLACED ON (B)(6) 2012 DUE TO DUE LEAD DISLODGEMENT SUSPECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN CRM S.R.L. | REPLY SR | 2587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |