BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 2822085 · Received October 9, 2012

    Report

    Report Number
    1028232-2012-02512
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    August 26, 2012
    Report Date
    September 28, 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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE VISUAL ANALYSIS DEMONSTRATED A RUBBED THROUGH INSULATION AT THE DISTAL PART OF THE LEAD. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATION OF THE VCS SHOCK COIL AS WELL AS THE CUTTINGS OF THE INSULATION RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS PT WAS INAPPROPRIATELY SHOCKED 32 TIMES. IT WAS AGREED BY MULTIPLE DOCTORS THAT THERE WAS NO T-WAVE OVERSENSING, ALTHOUGH OVERSENSING WAS SEEN. WHEN THE LEAD WAS EXPLANTED, IT APPEARED TO HAVE A KINK BUT NO OTHER VISUAL DAMAGE. AT THE TIME OF THE LEAD EXPLANT AND REPLACEMENT, THE ASSOCIATED ICD WAS ALSO REPLACED. ON (B)(6) 2012 - THIS DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization