BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1925934 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02301
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) A CAUSE OF THE RAPID BATTERY DEPLETION WAS NOT DETERMINED. EXAMINATION OF THE SAVE TO DISK DATA INDICATES THAT A HIGH CURRENT CONDITION EXISTED WHEN THE BATTERY WAS APPROXIMATELY 3.1 VOLTS AND THEN CLEARED WHEN THE BATTERY REACHED APPROXIMATELY 2.6 VOLTS. THE DEVICE WAS MONITORED AND EXAMINED IN VARIOUS MODES IN ATTEMPTS TO INDUCE A HIGH CURRENT CONDITION. A HIGH CURRENT CONDITION WAS NOT OBSERVED DURING EVALUATION OF THE DEVICE. THE SAVE TO DISK DATA ALSO SHOWED THAT THE DEVICE INDICATED BATTERY DEPLETION (ELECTIVE REPLACEMENT INDICATOR ERI). ERI WAS INDICATED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY HAVE AN EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT FO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY HAVE EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R