BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3100769 · Received May 8, 2013

    Report

    Report Number
    1028232-2013-01304
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 22, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED SOME 12.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. 2 CM OF LEAD BODY BETWEEN THE FRAGMENTS WERE NOT RETURNED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED DURING SURGERY. THE LEAD FRAGMENTS WERE EXTENSIVELY ANALYZED. THE INSPECTION DEMONSTRATED A DAMAGED INSULATION AT SOME 33 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THE COATING OF THE CONDUCTOR CABLE TO THE RING ELECTRODE WAS FOUND DAMAGED. THESE FINDINGS CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. 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 FORCES AS THE RESULT OF CLAVICULAR FIRST RIB ENTRAPMENT. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO INTERMITTENT OVERSENSING. THIS IS THE SECOND LEAD TO BE REPLACED FOR THIS ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201942 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization