BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS SR COATED

    MDR report key: 2891754 · Received November 21, 2012

    Report

    Report Number
    1028232-2012-02905
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED REVEALING SCRATCHES ON THE PACEMAKER HOUSING. FURTHERMORE, IT WAS NOTICED THAT THE SILICONE COATING WAS COMPLETELY ROLLED UP OVER THE HEADER INDICATING MECHANICAL FORCES DURING THE EXPLANTATION PROCEDURE. FURTHER INVESTIGATIONS OF THE HEADER REVEALED NO ANOMALIES. THE SET SCREW COULD BE EASILY SCREWED IN AND OUT, THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORE. ALL DIMENSIONS OF THE HEADER BORE WERE WITHIN THE RANGE REQUESTED BY THE (B)(4). ALSO THE SPRING ELEMENT OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. NEXT, THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER'S MEMORY CONTENT WAS ANALYSED INDICATING NO DEVIATIONS. THE BATTERY STATUS WAS FOUND TO BE "ERI" SINCE (B)(6) 2012. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED IN ERI-MODE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. ADDITIONALLY, A LONG-TERM PACING TEST WAS PERFORMED. THE THERAPY FUNCTIONALITY OF THE PACEMAKER PROVED TO BE FLAWLESS. THE PACEMAKER WAS IMPLANTED FOR APPROXIMATELY 100 MONTHS. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 96 MONTHS, AN INTERMITTENT LOSS OF CAPTURE WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE DATES OF IMPLANT AND EXPLANT WERE NOT REPORTED TO US. HOWEVER, THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS SR COATED PACEMAKER NVZ BIOTRONIK SE & CO. KG 122460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization