BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX TD 65/16

    MDR report key: 3984428 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002709
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 24, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND DISSECTED AT 51 CM PROXIMAL TO THE TIP. ONLY THE DISTAL SEGMENT WAS RETURNED FOR ANALYSIS. THE INSPECTION REVEALED MULTIPLE SIGNS OF WEAR ALONG THE LEAD SEGMENT. IN PARTICULAR, THE INSULATION WAS FOUND DAMAGED AT 32 CM PROXIMAL TO THE LEAD TIP. AT THIS POSITION THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THESE FINDINGS CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE CLINICAL OBSERVATION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR - FIRST RIB ENTRAPMENT. FURTHER INSPECTION REVEALED EXPLANTATION DAMAGES I.E. THE RV AND SVC SHOCK COILS WERE FOUND DEFORMED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT OVERSENSING AND A PROGRESSIVE DECREASE OF THE LEAD IMPEDANCE WAS NOTED VIA HOME MONITORING ABOUT 55 MONTHS AFTER THE IMPLANTATION. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461097 LINOX TD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization