BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVIA SKY DR-T

    MDR report key: 22088266 · Received May 27, 2025

    Report

    Report Number
    1028232-2025-02570
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 16, 2025
    Report Date
    September 23, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE PACEMAKER WAS INTERROGATED AND THE MEMORY CONTENT WAS ANALYZED, INDICATING NO ANOMALIES. THE BATTERY STATUS WAS BOS. THE HEADER OF THE DEVICE WAS ANALYZED. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT, THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORES. ALL DIMENSIONS OF THE HEADER BORES WERE WITHIN THE RANGE REQUESTED BY THE STANDARD SPECIFICATIONS. ALSO THE SPRING ELEMENTS OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. HOWEVER, IT WAS NOTED THAT THE SET SCREW OF THE RV CHANNEL DID NOT HAVE FIXATION MARKS UPON RECEIPT. THIS IS AN INDICATION THAT THE RV LEAD MIGHT NOT HAVE BEEN PROPERLY CONNECTED, THUS LEADING TO THE REPORTED LACK OF PACING SUPPORT. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. AN ADDITIONAL LONG-TERM PACING TEST WAS INITIATED. DURING THE TEST, EACH PACING PULSE WAS RECORDED. THE EVALUATION OF THESE PACING PULSES DOCUMENTED REGULAR DEVICE BEHAVIOR. THERE WAS NO INTERMITTENT OR PERMANENT LOSS OF OUTPUT. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS REVIEWED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. IN CONCLUSION, THE DEVICE IS FULLY FUNCTIONAL. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANTATION THIS PACEMAKER DID NOT PACE. IT WAS NOT IMPLANTED. A HEART-LUNG RESUSCITATOR (HLR) WAS APPLIED TO THE PACEMAKER DEPENDENT PATIENT UNTIL A NEW PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334059 AMVIA SKY DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 460160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization