BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRONIK DEFIBRILLATOR PACEMAKER LEAD

    MDR report key: 2781176 · Received October 9, 2012

    Report

    Report Number
    MW5027174
    Event Type
    Injury
    Date Received
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BIOTRONIK
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT ADVERSE REACTIONS TO TWO RECALLED LEADS. SHE SAID THE FIRST BIOTRONIK LEAD WAS IMPLANTED IN 2006, MODEL # RA-LEAD # 350973. THE SECOND LEAD IS ST. JUDE, MODEL # RVA-7120Q58. PATIENT STATED BOTH LEADS ARE RECALLED. SHE SAYS THE LEADS HAVE CAUSED HER TO BECOME VERY ILL. SHE SAID SHE EXPERIENCES SHARP PAINS AROUND THE SITE AND EXTREME CHEST PAIN. SHE DESCRIBED THE PAIN AS CONSTANT AND ALSO LIKE A BURNING SENSATION. PATIENT SAYS SHE IS EXTREMELY ILL AND CAN BARELY DO DAY-TO-DAY ACTIVITY. SHE STATED SHE HAS BEEN IN THE HOSPITAL AT LEAST 30 TIMES. SHE IS VERY UPSET AND SCARED FOR HER HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRONIK DEFIBRILLATOR PACEMAKER LEAD PACEMAKER LEAD NVZ BIOTRONIK RA-LEAD 350973
    2 ST. JUDE DEFIBRILLATOR PACEMAKER LEAD PACEMAKER LEAD NVZ ST. JUDE RVA-7120Q58

    Patients

    Seq Age Sex Outcome Treatment
    1