BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIA DR

    MDR report key: 4161239 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02306
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED, TELEMETERED BATTERY VOLTAGE OF DEVICE WHEN RECEIVED IN THE LAB WAS 3.21V WHICH IS CONSIDERED BOL (BEGINNING OF LIFE). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DECREASED BATTERY VOLTAGE. ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638031 CARDIA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D384DRG

    Patients

    Seq Age Sex Outcome Treatment
    1