BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3211815 · Received July 8, 2013

    Report

    Report Number
    1028232-2013-01853
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 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

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. UPON RECEIPT, THE LEAD WAS FOUND DISSECTED IN TWO FRAGMENTS, AT APPROXIMATELY 24 CM DISTAL TO THE IS-1 CONNECTOR PIN. A 3 CM LONG PORTION OF THE LEAD WAS MISSING BETWEEN THE TWO RECEIVED FRAGMENTS. THE ANALYSIS OF THE LEAD DEMONSTRATED MULTIPLE ABRASION MARKS ALONG THE LEAD BODY. IN PARTICULAR, A RUBBED THROUGH INSULATION WAS FOUND AT THE IS-1 CONNECTOR. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE CLINICAL OBSERVATION. BASED ON THE CHARACTERISTICS OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE AS A RESULT OF INTERACTION WITH THE ICD CAN. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE IMPEDANCE ON THE LEAD HAS RISEN OVER THE LAST 2 MONTHS FROM 45 OHMS TO 55 OHMS AND THERE HAS BEEN 10 EPISODES OF NOISE ON THE RV AND THE FF CHANNEL SINCE (B)(6) 2013 LEADING TO INAPPROPRIATE DETECTION AND DEVICE CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311434 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization