BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIA SR-T

    MDR report key: 3173915 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-01708
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED REVEALING NO ANOMALIES, IN PARTICULAR THE HEADER OF THE PACEMAKER WAS VISUAL ANALYZED. THE SET SCREW COULD BE EASILY SCREWED IN AND OUT AND THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORE. ALL DIMENSIONS OF THE HEADER BORES WERE WITHIN THE RANGE REQUESTED BY THE IS-1 STANDARD SPECIFICATIONS. ALSO THE SPRING ELEMENT OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED INDICATING NO DEVIATIONS. THE BATTERY WAS FOUND TO BE FULLY CHARGED. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. 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. 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.

    Description of Event or Problem · 1

    THIS SYSTEM DEMONSTRATED LOSS OF CAPTURE AND INTERMITTENT OUTPUT AT THE POST IMPLANT CHECK. THE NEXT DAY THE PHYSICIAN REPOSITIONED THE LEAD AND RECONNECTED IT TO THIS DEVICE. THE SYSTEM STILL HAD INTERMITTENT OUTPUT WHEN THE LEAD WAS COILED UNDER THE DEVICE. AFTER SEVERAL ATTEMPTS TO CLEAN THE LEAD TIP AND THE HEADER AND REPOSITION THE LEAD IN THE HEADER, THE PHYSICIAN REQUESTED A NEW DEVICE. THE NEW PACEMAKER, HAD THE SAME ISSUE, SO THE PHYSICIAN REPLACED THE LEAD WITH ANOTHER PACING LEAD, WHICH FUNCTIONED WITHOUT ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273010 EVIA SR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 359533

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization