BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 3071638 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01018
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 18, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. 693165 IMPLANTABLE TACHY LEAD 2007 (B)(6); (B)(4) IMPLANTABLE TACHY LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ALL LEADS WERE EXPLANTED DUE TO AN INFECTION. THE CHRONIC RIGHT VENTRICULAR LEAD WAS CAPPED SIX MONTHS PRIOR TO THE EXPLANT PROPHYLACTICALLY; HOWEVER AT THE TIME OF EXPLANT, THE PHYSICIAN SUSPECTED A LEAD FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171439 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R