BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2954729 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00488
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 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
    OTHER

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYSIS FOUND THAT THE DEVICE WAS IN A HIGH CURRENT DRAIN AND THAT WAS THE CAUSE FOR THE BATTERY DEPLETION. THE TELEMETRY AND PACING OUTPUTS WERE FULLY FUNCTIONAL. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE STACKED CHIP SCALE PACKAGE (SCSP) WAS OPTICALLY INSPECTED. COPPER TRACE ANOMALIES WERE NOTED BETWEEN TRACES AND 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 PARTICULAR LOCATIONS WAS SHOWN TO RESULT IN HIGHER THAN NOMINAL CURRENT DRAIN WHICH IS CONSISTENT WITH THE OBSERVED DEPLETED BATTERY. HOWEVER NO DEFINITIVE CONCLUSION CAN BE MADE FOR THE CAUSE OF FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENT FOLLOW-UP THE DEVICE REVEALED A NO TELEMETRY CONDITION. MULTIPLE PROGRAMMERS WERE USED TO TRY TO GAIN TELEMETRY WITHOUT SUCCESS. IT WAS ALSO REPORTED THAT A REMOTE MONITOR WAS NOT ABLE TO TRANSMIT THE DEVICE EITHER. 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
    59414 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD