BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2941709 · Received December 21, 2012

    Report

    Report Number
    1028232-2012-03234
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 9, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Additional Manufacturer Narrative · 1

    THE LEAD UNDER COMPLAINT WAS EXTENSIVELY ANALYZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE ANALYSIS REVEALED SEVERE ABRASION MARKS ALONG THE LEAD BODY. IN PARTICULAR, AT THE DISTAL PART OF THE LEAD THE INSULATION WAS RUBBED THROUGH. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THIS 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 CUTTINGS OF THE INSULATION RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 39 MONTHS OVERSENSING WAS REPORTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS EXPLANTED.

    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 UNK Hospitalization