FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 6329165
·
Received February 14, 2017
Report
- Report Number
- 1000165971-2017-00114
- Event Type
- Malfunction
- Date Received
- February 14, 2017
- Date of Event
- January 10, 2017
- Report Date
- January 18, 2017
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- DXY
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED ON (B)(6) 2010. REPORTEDLY, IT WAS FOUND IN VVI MODE AT 70 MIN-1 DURING LAST FOLLOW-UP. THE PATIENT HAD BEEN SEEN ONE YEAR AGO AND DEVICE HAD BEEN PROGRAMMED TO VVI MODE AT 60 MIN-1. AN ANALYSIS IS REQUESTED. PRELIMINARY ANALYSIS SHOWED THAT THE DEVICE SWITCHED IN STANDBY MODE DUE TO SEU (SINGLE EVENT UPSET).
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED ON (B)(6) 2010. REPORTEDLY, IT WAS FOUND IN VVI MODE AT 70 MIN-1 DURING LAST FOLLOW-UP. THE PATIENT HAD BEEN SEEN ONE YEAR AGO AND DEVICE HAD BEEN PROGRAMMED TO VVI MODE AT 60 MIN-1. AN ANALYSIS IS REQUESTED. PRELIMINARY ANALYSIS SHOWED THAT THE DEVICE SWITCHED IN STANDBY MODE DUE TO SEU (SINGLE EVENT UPSET).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113207 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | DXY | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY SR | 2456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |