BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2941710 · Received December 21, 2012

    Report

    Report Number
    1028232-2012-03235
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 13, 2012
    Report Date
    December 6, 2012
    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 PROXIMAL AND DISTAL FRAGMENT WERE RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED DURING SURGERY. THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION IN THE DISTAL PART OF THE LEAD. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED NOISE AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THESES DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATION OF THE RV SHOCK COIL OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 24 MONTHS, OVERSENSING ON RIGHT VENTRICLE LEAD CAUSING INAPPROPRIATE SHOCKS WAS REPORTED. NO ADVERSE OT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS EXPLANTED AND A NEW LEAD IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization