BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3153506 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01145
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. A 5076 IMPLANTABLE PACING LEAD, (B)(6) 2013. A 6947M IMPLANTABLE TACHY LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK POST IMPLANT, A DEVICE CHECK NOTED SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NSVT) EPISODES. A LOOSE LEAD PIN WAS SUSPECTED, HOWEVER, AT NSVT EPISODES, CROSSTALK SENSING OF ATRIAL PACING WAS GENERATED IN THE VENTRICLE AND A DEVICE FAILURE WAS SUSPECTED. AT A PRE-OP CHECK, THE NOISE REPEATABILITY WASN¿T CONFIRMED. DURING INCISING THE POCKET, NOISE HAD OCCURRED WHEN THE PHYSICIAN TOUCHED THE EPIDERMIS OF THE POCKET. A LOOSE PIN WASN¿T CONFIRMED AT THE LEAD CONNECTION AND NOISE INTERFUSION WASN¿T CONFIRMED WITH TENSILE FORCE AFTER THE DEVICE WAS EXPOSED. HOWEVER, TAPPING THE BODY AROUND THE CAVITY CONNECTION OF THE DEVICE AND LIGHTLY STRESSING THE DEVICE, NOISE INTERFUSION WAS CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED. WITH THE NEW DEVICE, NO NOISE WAS CONFIRMED ON THE SAME CONDITIONS AS ABOVE, AND CROSSTALK OF ATRIAL PACING WASN¿T GENERATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257742 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R