REPLY
Report
- Report Number
- 1000165971-2015-00662
- Event Type
- Injury
- Date Received
- November 2, 2015
- Date of Event
- September 30, 2015
- Report Date
- October 6, 2015
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- NVZ
- PMA / PMN Number
- PP950029
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
PHYSICIAN DECIDED TO PERFORM THE RECOMMENDED HARDWARE RESET PROCEDURE DURING A FOLLOW-UP SCHEDULED ON (B)(6) 2016. RECOMMENDATIONS WERE SENT ON (B)(6) 2016 TO PROVIDE THE PASSWORD NECESSARY TO PERFORM THE HARDWARE RESET PROCEDURE. PLEASE REFER TO THE ATTACHED PRELIMINARY ANALYSIS REPORT.
AT A PACEMAKER CHECK ON (B)(6) 2015, AFTER RADIATION THERAPY, IT WAS REPORTEDLY IMPOSSIBLE TO INTERROGATE THE PACEMAKER DUE TO WRONG POSITIONING OF THE TELEMETRY HEAD. THE PROGRAMMER WAS RESTARTED, AND THE PACEMAKER INTERROGATION WAS THEN SUCCESSFULLY PERFORMED. HOWEVER, PACEMAKER WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED SWITCH TO STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). TELEMETRY ERRORS OCCURRED DURING THE RE-INITIALIZATION PROCESS PERFORMED ON (B)(6) 2015, AND INTERRUPTED IT. CONSEQUENTLY, NORMAL BEHAVIOR OF THE PACEMAKER HAS BEEN RESTORED, EXCEPT FOR THE DISPLAY OF THE BATTERY TABLE WHICH HAS BEEN CORRUPTED. ONLY A HARDWARE RESET COULD RESTORE THE BATTERY TABLE.
AT A PACEMAKER CHECK ON (B)(6) 2015, AFTER RADIATION THERAPY, IT WAS REPORTEDLY IMPOSSIBLE TO INTERROGATE THE PACEMAKER DUE TO WRONG POSITIONING OF THE TELEMETRY HEAD. THE PROGRAMMER WAS RESTARTED, AND THE PACEMAKER INTERROGATION WAS THEN SUCCESSFULLY PERFORMED. HOWEVER, PACEMAKER WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED SWITCH TO STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). TELEMETRY ERRORS OCCURRED DURING THE RE-INITIALIZATION PROCESS PERFORMED ON (B)(6) 2015, AND INTERRUPTED IT. CONSEQUENTLY, NORMAL BEHAVIOR OF THE PACEMAKER HAS BEEN RESTORED, EXCEPT FOR THE DISPLAY OF THE BATTERY TABLE WHICH HAS BEEN CORRUPTED. ONLY A HARDWARE RESET COULD RESTORE THE BATTERY TABLE.
AT A PACEMAKER CHECK ON (B)(6) 2015, AFTER RADIATION THERAPY, IT WAS REPORTEDLY IMPOSSIBLE TO INTERROGATE THE PACEMAKER DUE TO WRONG POSITIONING OF THE TELEMETRY HEAD. THE PROGRAMMER WAS RESTARTED, AND THE PACEMAKER INTERROGATION WAS THEN SUCCESSFULLY PERFORMED. HOWEVER, PACEMAKER WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED SWITCH TO STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). TELEMETRY ERRORS OCCURRED DURING THE RE-INITIALIZATION PROCESS PERFORMED ON (B)(6) 2015, AND INTERRUPTED IT. CONSEQUENTLY, NORMAL BEHAVIOR OF THE PACEMAKER HAS BEEN RESTORED, EXCEPT FOR THE DISPLAY OF THE BATTERY TABLE WHICH HAS BEEN CORRUPTED. ONLY A HARDWARE RESET COULD RESTORE THE BATTERY TABLE.
AT A PACEMAKER CHECK ON (B)(6) 2015, AFTER RADIATION THERAPY, IT WAS REPORTEDLY IMPOSSIBLE TO INTERROGATE THE PACEMAKER DUE TO WRONG POSITIONING OF THE TELEMETRY HEAD. THE PROGRAMMER WAS RESTARTED, AND THE PACEMAKER INTERROGATION WAS THEN SUCCESSFULLY PERFORMED. HOWEVER, PACEMAKER WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED SWITCH TO STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). TELEMETRY ERRORS OCCURRED DURING THE RE-INITIALIZATION PROCESS PERFORMED ON (B)(6) 2015, AND INTERRUPTED IT. CONSEQUENTLY, NORMAL BEHAVIOR OF THE PACEMAKER HAS BEEN RESTORED, EXCEPT FOR THE DISPLAY OF THE BATTERY TABLE WHICH HAS BEEN CORRUPTED. ONLY A HARDWARE RESET COULD RESTORE THE BATTERY TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725216 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY DR | 2511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |