BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2844880 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02754
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCES AFTER A ROUTINE DEVICE CHANGE OUT. PRIOR TO THE REPLACEMENT, THIS LEAD HAD NORMAL, WITHIN RANGE MEASUREMENTS. AFTER DISCONNECTING THIS LEAD FROM THE OLD COMPETITIVE ICD, THIS LEAD WAS TESTED ON A MEDTRONIC PSA AND HIGH IMPEDANCES WERE NOTED ON THE SHOCK COILS. THE LEAD WAS CONNECTED TO THE NEW ICD AND HIGH SHOCK IMPEDANCES WERE NOTED AGAIN. THE PHYSICIAN DID NOT FEEL COMFORTABLE DOING A DFT TEST AT THIS TIME, SO THE POCKET WAS CLOSED AND TECHNICAL SERVICES (TSV) WAS CONSULTED. TSV RECOMMENDED A 1J TEST SHOCK, WHICH ALSO SHOWED AN OUT OF RANGE SHOCK IMPEDANCE, SO EXPLANT WAS RECOMMENDED. THE LEAD WAS EXPLANTED ON (B)(6) 2012. THE LEAD WAS EXAMINED WITH FLUOROSCOPY AND VISUALLY UPON EXTRACTION. AND THE PHYSICIAN DID NOT NOTICE ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization