BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 3862492 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01376
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, AN X-RAY SHOWED THAT THE DEVICE CHANGED POSITION. THE PHYSICIAN DID A POCKET REVISION AND THE DEVICE IS STILL IN USE. AT THE TIME OF THE REVISION, THE PHYSICIAN ELECTED TO REPLACE THE LEAD "JUST TO BE SURE". THERE WERE NO INDICATIONS OF ANY LEAD MALFUNCTIONS. THE LEAD 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
    339391 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6935M62 LEAD