BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2941707 · Received December 21, 2012

    Report

    Report Number
    1028232-2012-03233
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 8, 2012
    Report Date
    December 6, 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 FOUND DISSECTED SOME 52 CM PROXIMAL THE LEAD TIP. THE PROXIMAL PART OF THE LEAD WAS MISSING. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE SURGERY. THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION. 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 OF THESES DAMAGES, 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 CUTTINGS OF THE INSULATION, THE DEFORMATION OF THE RV SHOCK COIL AND THE DAMAGED LEAD TIP ARE MOST LIKELY RELATED TO THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER THE IMPLANT DURATION OF 32 MONTHS OVERSENSING WAS REPORTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization