BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3201593 · Received July 2, 2013

    Report

    Report Number
    1028232-2013-01840
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 21, 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

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. THE DF-1 CONNECTOR WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS OF THE TWO LEAD FRAGMENTS DEMONSTRATED A RUBBED THROUGH INSULATION AT ABOUT 15 CM DISTAL TO THE IS-1 CONNECTOR PIN. THE COATING OF THE CONDUCTOR CABLE TO THE RING ELECTRODE WAS FOUND DAMAGED IN THIS AREA. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE CLINICAL OBSERVATION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF MECHANICAL INTERACTION BETWEEN THE LEAD BODY AND THE ICD CAN. FURTHER DAMAGES OCCURRED MOST LIKELY 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 IMPLANTATIONS PERIOD OF ABOUT 57 MONTHS, AN IMPEDANCE INCREASE WAS REPORTED. AS THE LEAD WAS DAMAGED DURING THE EXPLANTATION PROCEDURE, ONLY FRAGMENTS WERE RECEIVED FOR ANALYSIS. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE EXPLANT AND EVENT DATES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303355 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization