FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 4112702
·
Received September 24, 2014
Report
- Report Number
- 1000165971-2014-00542
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- August 26, 2014
- Report Date
- August 29, 2014
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- NVZ
- PMA / PMN Number
- PP950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT FOLLOWING CARDIOVERSION (300 JOULE), PACING FAILURE AND ABSENCE OF TELEMETRY RELATIVE TO THE SUBJECT DEVICE RESULTED. REPORTEDLY, THE CARDIOVERSION HAD BEEN DONE INAPPROPRIATELY, SINCE AN ELECTRODE WAS PLACED ABOVE THE PACEMAKER.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT FOLLOWING CARDIOVERSION (300 JOULE), PACING FAILURE AND ABSENCE OF TELEMETRY RELATIVE TO THE SUBJECT DEVICE RESULTED. REPORTEDLY, THE CARDIOVERSION HAD BEEN DONE INAPPROPRIATELY, SINCE AN ELECTRODE WAS PLACED ABOVE THE PACEMAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596036 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | ESPRIT DR | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |