BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 75/18

    MDR report key: 2231025 · Received July 19, 2011

    Report

    Report Number
    1028232-2011-01570
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED 8 SHOCKS FOR VT. ALL SHOCKS DISPLAYED A SHOCK IMPEDANCE OF LESS THEN 25 OHMS AND WERE INEFFECTIVE. AFTER THE EPISODE, THE ATRIAL IMPEDANCE WAS GREATER THAN 3000 OHMS AND VENTRICULAR IMPEDANCE WAS 2728 OHMS. UPON INTERROGATION, AN ERROR MESSAGE WAS DISPLAYED. THIS DEVICE WAS CAPPED (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 75/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350056

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization