BEUDAMED
    FDA Adverse Event Other Summary report: N

    TACHOS DR

    MDR report key: 523189 · Received April 30, 2004

    Report

    Report Number
    1028232-2004-00062
    Event Type
    Other
    Date Received
    April 30, 2004
    Date of Event
    April 29, 2004
    Report Date
    April 30, 2004
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    VOLUNTARY FIRM INITIATED DEVICE RECALL EXTENSION IN 2004 ASSOCIATED WITH VOLUNTARY RECALL DATE 02/2004. THE MANUFACTURER NOTIFIED BIOTRONIK, INC. THAT U.S. PRODUCT WAS SUBJECT TO THE ATTACHED DEAR DOCTOR LETTER. IN FEBRUARY 2003, BIOTRONIK INITIATED A "VOLUNTARY MEDICAL DEVICE RECALL" OF THE TACHOS DR, TACHOS DR-ATRIAL TX AND DEIKOS A+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS [ICDS] DUE TO AN UNEXPECTEDLY HIGH INCIDENCE OF EARLY EXPLANTATIONS. THE CAUSE OF THESE EARLY EXPLANTS WAS A PREMATURE BUILDUP OF A PASSIVATION LAYER ON THE ANODE OF THE HIGH VOLTAGE BATTERY. THIS BUILDUP RESULTS IN A TRANSIENT INCREASE IN INTERNAL CELL IMPEDANCE, WHICH DECREASES THE LOADED [I.E., DURING CHARGING] BATTERY VOLTAGE AND POTENTIALLY LIMITS THE CELL'S ABILITY TO GENERATE THE FULL AMOUNT OF ENERGY. TO DATE COMPANY HAS RECEIVED NO REPORTS OF ANY PT DEATHS OR SERIOUS INJURIES ASSOCIATED WITH THIS PHENOMENON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACHOS DR ICD MRM BIOTRONIK GMBH & CO. 335 572 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other