BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA DR

    MDR report key: 5861632 · Received August 9, 2016

    Report

    Report Number
    9614453-2016-05323
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 12, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD A LEAD INTEGRITY ALERT (LIA) THREE YEARS AGO AND THEN AGAIN RECENTLY DUE TO SENSING INTEGRITY COUNTER (SIC) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. ADDITIONALLY, THERE WAS A SUSPECTED CONNECTION ISSUE WITH THE DEVICE. THE LEAD AND DEVICE 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
    508881 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D364DRG

    Patients

    Seq Age Sex Outcome Treatment
    1