REPLY
Report
- Report Number
- 1000165971-2014-00296
- Event Type
- Injury
- Date Received
- May 23, 2014
- Date of Event
- April 18, 2014
- Report Date
- April 23, 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
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
ANALYSIS RESULTS SUGGEST A LEAD OR A CONNECTION ISSUE AT ATRIAL LEVEL. RECOMMENDATIONS HAVE BEEN PROVIDED ON 1 AUGUST 2014. NEW FILES RECEIVED FOR THE FOLLOW-UP PERFORMED ON 25 JULY 2014.
DURING A REGULAR PACEMAKER CHECK ON (B)(6) 2014, A MESSAGE SHOWING THAT THE DEVICE IS IN STANDBY MODE WAS DISPLAYED. NO OTHER MESSAGES WERE DISPLAYED AT THAT TIME. DURING ATRIAL SENSITIVITY TEST, IT WAS UNABLE TO MEASURE ATRIAL SENSING AMPLITUDE (AP-VP MARKERS WERE DISPLAYED), EVEN AFTER RE-PROGRAMMING THE ATRIAL SENSITIVITY TO MORE SENSITIVE VALUES. DURING ATRIAL PACING THRESHOLD TEST, CAPTURE FAILURE WAS OBSERVED. ATRIAL THRESHOLD WAS ALSO IMMEASURABLE. SINCE ATRIAL LEAD IMPEDANCE WAS MEASURED ABOVE 3000OHMS, LEAD FRACTURE WAS SUSPECTED. ATRIAL LEAD POLARITY WAS THEN CHANGED FROM BIPOLAR TO UNIPOLAR SETTINGS BUT CAPTURE FAILURE WAS ALSO OBSERVED DURING PACING THRESHOLD TEST. LEAD FRACTURE POINT WAS NOT IDENTIFIED ON X-RAY PHOTO. PACING MODE WAS RE-PROGRAMMED FROM DDDR (WITH MV+G SENSOR) TO VVIR (WITH MV+G SENSOR) AT THE END OF THIS FOLLOW-UP. THE NEXT FOLLOW-UP WILL BE PERFORMED IN THREE MONTHS. AN ANALYSIS IS REQUESTED. PRELIMINARY ANALYSIS SHOWED A LEAD OR CONNECTION ISSUE AT ATRIAL SIDE.
DURING A REGULAR PACEMAKER CHECK ON (B)(6) 2014, A MESSAGE SHOWING THAT THE DEVICE IS IN STANDBY MODE WAS DISPLAYED. NO OTHER MESSAGES WERE DISPLAYED AT THAT TIME. DURING ATRIAL SENSITIVITY TEST, IT WAS UNABLE TO MEASURE ATRIAL SENSING AMPLITUDE (AP-VP MARKERS WERE DISPLAYED), EVEN AFTER RE-PROGRAMMING THE ATRIAL SENSITIVITY TO MORE SENSITIVE VALUES. DURING ATRIAL PACING THRESHOLD TEST, CAPTURE FAILURE WAS OBSERVED. ATRIAL THRESHOLD WAS ALSO IMMEASURABLE. SINCE ATRIAL LEAD IMPEDANCE WAS MEASURED ABOVE 3000OHMS, LEAD FRACTURE WAS SUSPECTED. ATRIAL LEAD POLARITY WAS THEN CHANGED FROM BIPOLAR TO UNIPOLAR SETTINGS BUT CAPTURE FAILURE WAS ALSO OBSERVED DURING PACING THRESHOLD TEST. LEAD FRACTURE POINT WAS NOT IDENTIFIED ON X-RAY PHOTO. PACING MODE WAS RE-PROGRAMMED FROM DDDR (WITH MV+G SENSOR) TO VVIR (WITH MV+G SENSOR) AT THE END OF THIS FOLLOW-UP. THE NEXT FOLLOW-UP WILL BE PERFORMED IN THREE MONTHS. AN ANALYSIS IS REQUESTED. PRELIMINARY ANALYSIS SHOWED A LEAD OR CONNECTION ISSUE AT ATRIAL SIDE.
DURING A REGULAR PACEMAKER CHECK ON (B)(6) 2014, A MESSAGE SHOWING THAT THE DEVICE IS IN STANDBY MODE WAS DISPLAYED. NO OTHER MESSAGES WERE DISPLAYED AT THAT TIME. DURING ATRIAL SENSITIVITY TEST, IT WAS UNABLE TO MEASURE ATRIAL SENSING AMPLITUDE (AP-VP MARKERS WERE DISPLAYED), EVEN AFTER RE-PROGRAMMING THE ATRIAL SENSITIVITY TO MORE SENSITIVE VALUES. DURING ATRIAL PACING THRESHOLD TEST, CAPTURE FAILURE WAS OBSERVED. ATRIAL THRESHOLD WAS ALSO IMMEASURABLE. SINCE ATRIAL LEAD IMPEDANCE WAS MEASURED ABOVE 3000OHMS, LEAD FRACTURE WAS SUSPECTED. ATRIAL LEAD POLARITY WAS THEN CHANGED FROM BIPOLAR TO UNIPOLAR SETTINGS BUT CAPTURE FAILURE WAS ALSO OBSERVED DURING PACING THRESHOLD TEST. LEAD FRACTURE POINT WAS NOT IDENTIFIED ON X-RAY PHOTO. PACING MODE WAS RE-PROGRAMMED FROM DDDR (WITH MV+G SENSOR) TO VVIR (WITH MV+G SENSOR) AT THE END OF THIS FOLLOW-UP. THE NEXT FOLLOW-UP WILL BE PERFORMED IN THREE MONTHS. AN ANALYSIS IS REQUESTED. PRELIMINARY ANALYSIS SHOWED A LEAD OR CONNECTION ISSUE AT ATRIAL SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307811 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY DR | 2587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |