REPLY
Report
- Report Number
- 1000165971-2016-00849
- Event Type
- Injury
- Date Received
- December 23, 2016
- Date of Event
- November 25, 2016
- Report Date
- November 28, 2016
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- DTB
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
REPORTEDLY, UPON INTERROGATION ON (B)(6) 2017, THE PACEMAKER HAD REACHED THE RRT (RECOMMENDED REPLACEMENT TIME) AND WAS OPERATING IN VVI MODE WITH A BASIC RATE AT 70 MIN-1. THEREFORE, THE PLANNED HARDWARE RESET PROCEDURE WAS NOT PERFORMED. AS THE PATIENT HAD NO SPONTANEOUS RHYTHM, USE OF A TEMPORARY PACING SYSTEM WAS CONSIDERED. REPLACEMENT OF THE PACEMAKER WAS PERFORMED ON (B)(6) 2017, AND THE DEVICE WAS RETURNED FOR ANALYSIS.
PLEASE REFER TO THE ATTACHED PRELIMINARY ANALYSIS REPORT. THE PASSWORD WAS PROVIDED FOR THE HARDWARE RESET PROCEDURE REPORTEDLY SCHEDULED ON (B)(6) 2017.
PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED WITHIN SPECIFICATIONS.
REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016 IN THE MORNING, INTERROGATION OF THE SUBJECT PACEMAKER WAS STOPPED IN THE MIDDLE AND THE INTERROGATION PROCESS WAS NOT COMPLETED. THE PACEMAKER COULD STILL NOT BE INTERROGATED AFTER THE PROGRAMMER WAS REBOOTED, AND NEITHER WITH ANOTHER PROGRAMMER. AN ECG RECORDED BEFORE THE ATTEMPTS TO INTERROGATE THE PACEMAKER SHOWED THAT THE PACEMAKER WAS PACING AT MAGNET RATE IN BOTH CHANNELS. PATIENT CAME BACK TO THE HOSPITAL IN THE AFTERNOON. A MAGNET WAS APPLIED ON THE PACEMAKER POCKET AND THEN REMOVED. AS A RESULT, NORMAL PACEMAKER OPERATION WAS RESTORED AND INTERROGATION COULD BE PERFORMED WITHOUT ANY ISSUE. UPON INTERROGATION, IT WAS REPORTEDLY OBSERVED THAT THE PACEMAKER WAS PACING AT MAGNET RATE SINCE AT LEAST ONE WEEK. THE PATIENT REPORTEDLY DID NOT HAVE ANY CONTACT WITH MAGNETIC FIELDS, AND DID NOT UNDERGO PARTICULAR MEDICAL EXAMINATIONS IN THE LAST 6 MONTHS. THE NEXT FOLLOW-UP HAS BEEN SCHEDULED FOR (B)(6) 2017. PRELIMINARY ANALYSIS SHOWED THAT THE BLOCKAGE OF THE PACEMAKER IN MAGNET MODE MOST PROBABLY RESULTED FROM A SINGLE EVENT UPSET (SEU). THE CORRUPTED MEMORY CELL INVOLVED WAS DEDICATED TO MAGNET MODE OPERATION, EXPLAINING THE REPORTED BEHAVIOR. APPLYING AND THEN REMOVING A MAGNET RESTORED NORMAL BEHAVIOR OF THE PACEMAKER.
REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016 IN THE MORNING, INTERROGATION OF THE SUBJECT PACEMAKER WAS STOPPED IN THE MIDDLE AND THE INTERROGATION PROCESS WAS NOT COMPLETED. THE PACEMAKER COULD STILL NOT BE INTERROGATED AFTER THE PROGRAMMER WAS REBOOTED, AND NEITHER WITH ANOTHER PROGRAMMER. AN ECG RECORDED BEFORE THE ATTEMPTS TO INTERROGATE THE PACEMAKER SHOWED THAT THE PACEMAKER WAS PACING AT MAGNET RATE IN BOTH CHANNELS. PATIENT CAME BACK TO THE HOSPITAL IN THE AFTERNOON. A MAGNET WAS APPLIED ON THE PACEMAKER POCKET AND THEN REMOVED. AS A RESULT, NORMAL PACEMAKER OPERATION WAS RESTORED AND INTERROGATION COULD BE PERFORMED WITHOUT ANY ISSUE. UPON INTERROGATION, IT WAS REPORTEDLY OBSERVED THAT THE PACEMAKER WAS PACING AT MAGNET RATE SINCE AT LEAST ONE WEEK. THE PATIENT REPORTEDLY DID NOT HAVE ANY CONTACT WITH MAGNETIC FIELDS, AND DID NOT UNDERGO PARTICULAR MEDICAL EXAMINATIONS IN THE LAST 6 MONTHS. THE NEXT FOLLOW-UP HAS BEEN SCHEDULED FOR (B)(6) 2017. PRELIMINARY ANALYSIS SHOWED THAT THE BLOCKAGE OF THE PACEMAKER IN MAGNET MODE MOST PROBABLY RESULTED FROM A SINGLE EVENT UPSET (SEU). THE CORRUPTED MEMORY CELL INVOLVED WAS DEDICATED TO MAGNET MODE OPERATION, EXPLAINING THE REPORTED BEHAVIOR. APPLYING AND THEN REMOVING A MAGNET RESTORED NORMAL BEHAVIOR OF THE PACEMAKER.
REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016 IN THE MORNING, INTERROGATION OF THE SUBJECT PACEMAKER WAS STOPPED IN THE MIDDLE AND THE INTERROGATION PROCESS WAS NOT COMPLETED. THE PACEMAKER COULD STILL NOT BE INTERROGATED AFTER THE PROGRAMMER WAS REBOOTED, AND NEITHER WITH ANOTHER PROGRAMMER. AN ECG RECORDED BEFORE THE ATTEMPTS TO INTERROGATE THE PACEMAKER SHOWED THAT THE PACEMAKER WAS PACING AT MAGNET RATE IN BOTH CHANNELS. PATIENT CAME BACK TO THE HOSPITAL IN THE AFTERNOON. A MAGNET WAS APPLIED ON THE PACEMAKER POCKET AND THEN REMOVED. AS A RESULT, NORMAL PACEMAKER OPERATION WAS RESTORED AND INTERROGATION COULD BE PERFORMED WITHOUT ANY ISSUE. UPON INTERROGATION, IT WAS REPORTEDLY OBSERVED THAT THE PACEMAKER WAS PACING AT MAGNET RATE SINCE AT LEAST ONE WEEK. THE PATIENT REPORTEDLY DID NOT HAVE ANY CONTACT WITH MAGNETIC FIELDS, AND DID NOT UNDERGO PARTICULAR MEDICAL EXAMINATIONS IN THE LAST 6 MONTHS. THE NEXT FOLLOW-UP HAS BEEN SCHEDULED FOR (B)(6) 2017. PRELIMINARY ANALYSIS SHOWED THAT THE BLOCKAGE OF THE PACEMAKER IN MAGNET MODE MOST PROBABLY RESULTED FROM A SINGLE EVENT UPSET (SEU). THE CORRUPTED MEMORY CELL INVOLVED WAS DEDICATED TO MAGNET MODE OPERATION, EXPLAINING THE REPORTED BEHAVIOR. APPLYING AND THEN REMOVING A MAGNET RESTORED NORMAL BEHAVIOR OF THE PACEMAKER.
REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016 IN THE MORNING, INTERROGATION OF THE SUBJECT PACEMAKER WAS STOPPED IN THE MIDDLE AND THE INTERROGATION PROCESS WAS NOT COMPLETED. THE PACEMAKER COULD STILL NOT BE INTERROGATED AFTER THE PROGRAMMER WAS REBOOTED, AND NEITHER WITH ANOTHER PROGRAMMER. AN ECG RECORDED BEFORE THE ATTEMPTS TO INTERROGATE THE PACEMAKER SHOWED THAT THE PACEMAKER WAS PACING AT MAGNET RATE IN BOTH CHANNELS. PATIENT CAME BACK TO THE HOSPITAL IN THE AFTERNOON. A MAGNET WAS APPLIED ON THE PACEMAKER POCKET AND THEN REMOVED. AS A RESULT, NORMAL PACEMAKER OPERATION WAS RESTORED AND INTERROGATION COULD BE PERFORMED WITHOUT ANY ISSUE. UPON INTERROGATION, IT WAS REPORTEDLY OBSERVED THAT THE PACEMAKER WAS PACING AT MAGNET RATE SINCE AT LEAST ONE WEEK. THE PATIENT REPORTEDLY DID NOT HAVE ANY CONTACT WITH MAGNETIC FIELDS, AND DID NOT UNDERGO PARTICULAR MEDICAL EXAMINATIONS IN THE LAST 6 MONTHS. THE NEXT FOLLOW-UP HAS BEEN SCHEDULED FOR (B)(6) 2017. PRELIMINARY ANALYSIS SHOWED THAT THE BLOCKAGE OF THE PACEMAKER IN MAGNET MODE MOST PROBABLY RESULTED FROM A SINGLE EVENT UPSET (SEU). THE CORRUPTED MEMORY CELL INVOLVED WAS DEDICATED TO MAGNET MODE OPERATION, EXPLAINING THE REPORTED BEHAVIOR. APPLYING AND THEN REMOVING A MAGNET RESTORED NORMAL BEHAVIOR OF THE PACEMAKER.
REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016 IN THE MORNING, INTERROGATION OF THE SUBJECT PACEMAKER WAS STOPPED IN THE MIDDLE AND THE INTERROGATION PROCESS WAS NOT COMPLETED. THE PACEMAKER COULD STILL NOT BE INTERROGATED AFTER THE PROGRAMMER WAS REBOOTED, AND NEITHER WITH ANOTHER PROGRAMMER. AN ECG RECORDED BEFORE THE ATTEMPTS TO INTERROGATE THE PACEMAKER SHOWED THAT THE PACEMAKER WAS PACING AT MAGNET RATE IN BOTH CHANNELS. PATIENT CAME BACK TO THE HOSPITAL IN THE AFTERNOON. A MAGNET WAS APPLIED ON THE PACEMAKER POCKET AND THEN REMOVED. AS A RESULT, NORMAL PACEMAKER OPERATION WAS RESTORED AND INTERROGATION COULD BE PERFORMED WITHOUT ANY ISSUE. UPON INTERROGATION, IT WAS REPORTEDLY OBSERVED THAT THE PACEMAKER WAS PACING AT MAGNET RATE SINCE AT LEAST ONE WEEK. THE PATIENT REPORTEDLY DID NOT HAVE ANY CONTACT WITH MAGNETIC FIELDS, AND DID NOT UNDERGO PARTICULAR MEDICAL EXAMINATIONS IN THE LAST 6 MONTHS. THE NEXT FOLLOW-UP HAS BEEN SCHEDULED FOR (B)(6) 2017. PRELIMINARY ANALYSIS SHOWED THAT THE BLOCKAGE OF THE PACEMAKER IN MAGNET MODE MOST PROBABLY RESULTED FROM A SINGLE EVENT UPSET (SEU). THE CORRUPTED MEMORY CELL INVOLVED WAS DEDICATED TO MAGNET MODE OPERATION, EXPLAINING THE REPORTED BEHAVIOR. APPLYING AND THEN REMOVING A MAGNET RESTORED NORMAL BEHAVIOR OF THE PACEMAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851812 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | DTB | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY DR | 2362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |