FDA Adverse Event
Injury
Summary report: N
ESPRIT
MDR report key: 2780758
·
Received October 5, 2012
Report
- Report Number
- 1000165971-2012-00366
- Event Type
- Injury
- Date Received
- October 5, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 19, 2012
- Manufacturer
- SORIN CRM S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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
SUBJECT PACEMAKER WAS IMPLANTED IN 2011. REPORTEDLY, AN EMERGENCY DEFIBRILLATION WAS DELIVERED TO THE PT ON (B)(6) 2012. ON (B)(6) 2012, IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE AND THE PROGRAMMER DISPLAYED AN ERROR MESSAGE. ASYNCHRONOUS PACING WAS VISIBLE. ON (B)(6) 2012, IT WAS ATTEMPTED TO COMPLETELY RESET THE PACEMAKER; NEVERTHELESS IT WAS STILL NOT POSSIBLE TO INTERROGATE THE DEVICE AFTERWARDS. THEREFORE, DEVICE REPLACEMENT HAS BEEN RECOMMENDED FOR THIS PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPRIT | NVZ | SORIN CRM S.R.L. | ESPRIT DR | 2491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |