BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2062996 · Received April 11, 2011

    Report

    Report Number
    1028232-2011-00807
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    April 4, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE LEAD ITSELF WAS FOUND DISSECTED IN TWO PARTS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE LEAD EXPLANTATION. THE ANALYSIS OF THE LEAD FRAGMENTS DEMONSTRATED A RUBBED THROUGH INSULATION. BASED ON THE CHARACTERISTICS OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO ABNORMAL MECHANICAL STRESS IN THE IMPLANTED STATE. THE INTERACTION WITH THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. 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 2 YEARS, THIS LEAD WAS EXPLANTED DUE TO A LEAD FRACTURE. THE EXACT IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    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