BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2952114 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00086
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS CONFIRMED THE "NO TELEMETRY" REPORTED AND ALSO NOTED "NO PACING OUTPUT." INITIAL MEASUREMENTS DETERMINED THAT THE DEVICE IS IN A HIGH CURRENT DRAIN CONDITION AND IS THE CAUSE FOR THE BATTERY DEPLETION. THE BATTERY DEPLETION ALSO CAUSED THE REPORTED "NO TELEMETRY." CONCOMITANT PRODUCT: 6947M IMPLANTABLE TACHY LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT HAVE TELEMETRY. WHILE ATTEMPTING TO INTERROGATE A DEVICE IMPLANTED FOR 6 MONTHS, THE CLINIC WAS UNABLE TO ESTABLISH TELEMETRY. ATTEMPTS WERE MADE TO ESTABLISH TELEMETRY USING A DIFFERENT PROGRAMMER, REPOSITIONING OF THE PROGRAMMER HEAD, AND PATIENT CHANGING POSITION ALL WITHOUT SUCCESS. AN ELECTROCARDIOGRAM DETERMINED THAT THE DEVICE WAS NOT PACING AND THE PATIENT'S HEART RATE WAS BELOW THE PROGRAMMED LOWER RATE SETTING. THE PATIENT HAD NO SYMPTOMS. BEFORE DEVICE REPLACEMENT, INTERROGATION WAS AGAIN ATTEMPTED BUT THERE WAS "NO BEHAVIOR." THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57205 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD