BEUDAMED
    FDA Adverse Event Summary report: N

    LINOX SD 65/16

    MDR report key: 1023697 · Received March 19, 2008

    Report

    Report Number
    1028232-2008-00333
    Date Received
    March 19, 2008
    Date of Event
    May 16, 2007
    Report Date
    February 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD WAS NOT DEFECTIVE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE MOLTEN TITANIUM SPOT INDICATES THAT THE CLINICAL OBSERVATION WAS CAUSED BY A COMPROMISED LEAD INSULATION OF THE HV-1 CONDUCTOR. ONCE THE HV-1 INSULATION IS COMPROMISED, AN ARC OVER MAY RESULT DURING A SHOCK DELIVERY BETWEEN THE ICD HOUSING AND THE HV-1 CONDUCTOR, CAUSING LOCALLY MOLTEN TITANIUM SPOTS. THIS IS CONSISTENT WITH THE ANALYSIS OF THE LEAD, DEMONSTRATING THAT IN A DISTANCE OF SOME 24 CM DISTAL TO THE IS-1 CONNECTOR, THE OUTER INSULATION WAS FOUND DAMAGED. IN PARTICULAR, THE OUTER INSULATION SURROUNDING THE CONNECTOR CABLE TOWARDS THE RING ELECTRODE WAS DAMAGED. THIS LACK OF INSULATION CORRESPONDED TO AN INCREASE IN THE ELECTRICALLY ACTIVE SURFACE RESPONSIBLE FOR SENSING. IT IS REASONABLE TO ASSUME THAT THIS IS THE ROOT CAUSE OF THE OBSERVED NOISE RESULTING IN THE OVERSENSING. DAMAGE SYMPTOMS, SUCH AS THOSE FOUND WITH IN THE SCOPE OF THE ANALYSES REQUIRE THE PRESENCE OF EXCESSIVE, CONTINUOUS AND LOCALIZED MECHANICAL STRESS SUCH AS THOSE DUE TO COMPRESSION FORCES. IT IS ANTICIPATED THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES WHILE IMPLANTED. LIGATURE MARKS ON THE LEAD BODY THAT WOULD BE HELPFUL TO ESTIMATE THE POSITON OF THE LEAD, COULD NOT BE DETECTED. DIAGNOSTIC IMAGES OF THE SYSTEM WHILE IMPLANTED WERE NOT AVAILABLE. AS AN ADDITIONAL FACT, THE PROXIMAL SHOCK COIL WAS FOUND ELONGATED. THIS WAS DUE TO MECHANICAL STRESS. MECHANICAL FORCES SUCH AS TRACTION FORCES, DURING THE EXPLANTATION PROCEDURE SHOULD BE TAKEN INTO CONSIDERATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    EXCESSIVE SHOCKS DUE TO LEAD NOISE. ALSO REMOVED: LUMOS VR-T, MDR 10282323-2008-00115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO. 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization