BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3152075 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01080
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 2, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ID: 694965 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COILS. IT WAS NOTED THAT THE PATIENT HAS BEEN SCREENED AND IT RESULTED THAT RV/SVC DEFIBRILLATION COILS WERE NOT FULLY INSERTED IN THE DEVICE¿S HEADER. THE PHYSICIAN WILL REOPEN THE POCKET TO ADJUST THIS PROBLEM. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252927 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R