BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3153688 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01158
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN THE HYBRID. ANALYSIS CONFIRMED A NO TELEMETRY AND NO OUTPUT CONDITION. INITIAL MEASUREMENTS DETERMINED THAT A HIGH CURRENT DRAIN CONDITION WAS THE CAUSE OF THE PREMATURE BATTERY DEPLETION. THE REPORTED NO TELEMETRY AND NO OUTPUT CONDITION WAS A RESULT OF THE DEPLETED BATTERY. AFTER THE DEVICE SAT UNBIASED FOR 24 HOURS, AN EXTERNAL SUPPLY WAS APPLIED TO THE DEVICE AND NOMINAL CURRENT DRAIN WAS MEASURED. THE STACKED CHIP SCALE PACKAGE (SCSP) WAS OPTICALLY INSPECTED. COPPER TRACE ANOMALIES WERE NOTED BETWEEN THE SEVERAL GROUPS OF EXPOSED TRACES IN THE SCSP SUBSTRATE. ELECTRICAL SHORTS CONSISTENT WITH THE LOCATION OF THE ANOMALIES WERE SIMULATED ON A SYSTEM BREADBOARD (SBB). THE SIMULATION OF SHORTS BETWEEN TWO OF THESE TRACES RESULTED IN HIGHER THAN NOMINAL CURRENT DRAIN CONSISTENT WITH THE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE FIRST DEVICE CHECK AFTER IMPLANT THE PATIENT FELT PAIN OVER THE POCKET FOR THREE DAYS. IT WAS ALSO REPORTED THAT APPROXIMATELY NINE MONTHS POST IMPLANT A SCHEDULED REMOTE TRANSMISSION FAILED, AND A MANUAL TRANSMISSION ALSO FAILED. THE PATIENT CAME TO THE CLINIC AND TWO OTHER PROGRAMMERS WERE TRIED BUT THERE WAS NO CONTACT WITH THE DEVICE. A MAGNET WAS ALSO APPLIED WITH NO RESPONSE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254551 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D364DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R