BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX TD 65/16

    MDR report key: 918438 · Received September 24, 2007

    Report

    Report Number
    1028232-2007-00377
    Event Type
    Injury
    Date Received
    September 24, 2007
    Date of Event
    June 11, 2007
    Report Date
    September 5, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. AS DESCRIBED IN THE COMPLAINT, ONLY A PROXIMAL PART OF THE LEAD HAD BEEN SENT IN FOR ANALYSIS. NO ANOMALIES COULD BE DETECTED AT THE AVAILABLE PROXIMAL LEAD FRAGMENT, SUCH AS A FRAYED INSULATION, FRACTURES OF THE CONDUCTORS OR SHORT CIRCUITS. THE ANALYSIS AT THE DISTAL LEAD FRAGMENT WAS UNABLE TO FIND A CAUSE FOR THE OVER SENSING AND THE INADEQUATE SHOCK DELIVERY.

    Description of Event or Problem · 1

    OUS MDR. INADEQUATE SHOCKS WERE DELIVERED IN 2007. A LESION COULD BE FELT ON THE EXPOSED LEAD DURING LEAD REVISION, ABOUT 1 CM NEXT TO THE INTRODUCER SHEATH (EFH). UNFORTUNATELY, THE SUSPICIOUS SPOT HAD TO REMAIN WITHIN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO. 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization