BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3232164 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01947
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 24, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    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

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL ANALYSIS. THE ANALYSIS OF THE LEAD DEMONSTRATED MULTIPLE SIGNS OF WEAR. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL STRESS IN THE IMPLANTED STATE. IN PARTICULAR AT APPROX. 26 CM DISTAL TO THE IS-1 CONNECTOR PIN, THE INSULATION WAS FOUND RUBBED THROUGH. INTERACTION BETWEEN THE LEAD BODY AND THE NEARBY LEAD SHOULD BE TAKEN INTO CONSIDERATION. FURTHER DAMAGES OCCURRED DURING 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 IMPLANTATION DURATION OF 49 MONTHS IT WAS REPORTED THAT THE PATIENT RECEIVED 3 INAPPROPRIATE SHOCKS. NO OTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332534 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization