REPLY
Received Oct 6, 2015 · Event occurred Sep 16, 2015
Report 1000165971-2015-00590 · MDR key 5130362
Device
Manufacturer
Sorin Group Italia S.r.l. - Crm FacilityModel number
REPLY VDRCatalog number
REPLY VDR
Lot number
2693
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Heart Failure
Narrative
Additional Manufacturer Narrative
THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.
Description of Event or Problem
ON (B)(6) 2015, ON A FOLLOW-UP PERFORMED ON A PATIENT WITH BACKGROUND OF ATRIAL FIBRILLATION, ALL THE MEASUREMENTS WERE NORMAL. IN ORDER TO PROMOTE THE SPONTANEOUS RHYTHM, DIFFERENT ATRIO VENTRICULAR (AV) INTERVALS WERE PROGRAMMED AND THE PATIENT STARTED TO FEEL BAD. WHEN PROGRAMMING THE AV INTERVAL TO 230/170 WITH A FREQUENCY OF 50 MIN-1, ACCORDING TO THE PHYSICIAN, WHEN CLICKING ON THE "PROGRAM" BUTTON, THE PROGRAMMER HEAD WAS MOVED FROM THE CORRECT POSITION AND THEN TELEMETRY WAS LOST. AT THAT MOMENT THE PATIENT SUFFERED A HEART FAILURE WITH LOSS OF SPHINCTER MUSCLE CONTROL AND A CARDIAC RESUSCITATION WAS NEEDED. THE PATIENT RECOVERED ESPECIALLY WHEN VVI MODE AT 80MIN-1 WAS PROGRAMMED. PRELIMINARY ANALYSIS SHOWED THAT RETROGRADE (VA) CONDUCTION WAS OBSERVED WITHIN THE FOLLOW-UP. THIS MAY HAVE BEEN CAUSED BY THE APPLICATION OF ASYNCHRONOUS MODES DURING THE TESTS PERFORMED WITHIN THE FOLLOW-UP AND/OR MODIFICATIONS OF TIMING PARAMETERS (RATES AND/OR AVD) AS REPORTED AND CONFIRMED THROUGH FILES ANALYSIS. THE RETROGRADE CONDUCTION WAS NOT OBSERVED ANYMORE AT THE END OF THE FOLLOW-UP.
Description of Event or Problem
ON SEPTEMBER 16TH, 2015, ON A FOLLOW-UP PERFORMED ON A PATIENT WITH BACKGROUND OF ATRIAL FIBRILLATION, ALL THE MEASUREMENTS WERE NORMAL. IN ORDER TO PROMOTE THE SPONTANEOUS RHYTHM, DIFFERENT ATRIO VENTRICULAR (AV) INTERVALS WERE PROGRAMMED AND THE PATIENT STARTED TO FEEL BAD. WHEN PROGRAMMING THE AV INTERVAL TO 230/170 WITH A FREQUENCY OF 50 MIN-1, ACCORDING TO THE PHYSICIAN, WHEN CLICKING ON THE ¿PROGRAM¿ BUTTON, THE PROGRAMMER HEAD WAS MOVED FROM THE CORRECT POSITION AND THEN TELEMETRY WAS LOST. AT THAT MOMENT, THE PATIENT SUFFERED A HEART FAILURE WITH LOSS OF SPHINCTER MUSCLE CONTROL AND A CARDIAC RESUSCITATION WAS NEEDED. THE PATIENT RECOVERED ESPECIALLY WHEN VVI MODE AT 80MIN-1 WAS PROGRAMMED. PRELIMINARY ANALYSIS SHOWED THAT RETROGRADE (VA) CONDUCTION WAS OBSERVED WITHIN THE FOLLOW-UP. THIS MAY HAVE BEEN CAUSED BY THE APPLICATION OF ASYNCHRONOUS MODES DURING THE TESTS PERFORMED WITHIN THE FOLLOW-UP AND/OR MODIFICATIONS OF TIMING PARAMETERS (RATES AND/OR AVD) AS REPORTED AND CONFIRMED THROUGH FILES ANALYSIS. THE RETROGRADE CONDUCTION WAS NOT OBSERVED ANYMORE AT THE END OF THE FOLLOW-UP.