FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 4054556
·
Received September 3, 2014
Report
- Report Number
- 1000165971-2014-00508
- Event Type
- Injury
- Date Received
- September 3, 2014
- Date of Event
- August 18, 2014
- Report Date
- August 28, 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
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY ANALYSIS CONFIRMED THE REPORTED SWITCH TO STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY REINITIALIZED DURING THE FOLLOW-UP OF (B)(4) 2014 AND ITS NORMAL FUNCTIONING WAS RESTORED.
Description of Event or Problem · 1
PACEMAKER REPORTEDLY REVERTED TO BACK-UP MODE FOLLOWING RETURN FOR AIR TRAVEL. PATIENT CAME FOR UNSCHEDULED FOLLOW-UP ON (B)(6) 2014 AND THE DEVICE WAS REPROGRAMMED.
Description of Event or Problem · 1
PACEMAKER REPORTEDLY REVERTED TO BACK-UP MODE FOLLOWING RETURN FOR AIR TRAVEL. PATIENT CAME FOR UNSCHEDULED FOLLOW-UP ON (B)(6) 2014 AND THE DEVICE WAS REPROGRAMMED.
Description of Event or Problem · 1
PACEMAKER REPORTEDLY REVERTED TO BACK-UP MODE FOLLOWING RETURN FOR AIR TRAVEL. PATIENT CAME FOR UNSCHEDULED FOLLOW-UP ON (B)(6) 2014 AND THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538541 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY DR | 2440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |