BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3232182 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01946
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. UPON RECEIPT, THE LEAD WAS FOUND DISSECTED AT APPROX. 40 CM DISTAL TO THE IS-1 CONNECTOR PIN. FIVE CENTIMETRES OF LEAD BODY BETWEEN THE TWO FRAGMENTS WERE NOT RETURNED FOR ANALYSIS. THE INSPECTION OF THE AVAILABLE LEAD FRAGMENTS REVEALED A RUBBED THROUGH INSULATION AT THE IS-1 CONNECTOR AND IN THE AREA OF THE TRICUSPID VALVE. THESE INSULATION DAMAGES CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED NOISE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AND THE LOCATION OF THESES DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE, AS A RESULT OF THE INTERACTION WITH THE ICD CAN AND THE TRICUSPID VALVE. THIS OBSERVATION COULD BE CONFIRMED THROUGH THE INSPECTION OF THE X-RAY IMAGES RETURNED FOR ANALYSIS. THE X-RAY IMAGES REVEALED AN AREA OF STRONG INTERACTION AND PRESSURE BETWEEN THE LEAD CONNECTOR AND THE ICD CAN AS WELL AS SEVERE SLACK IN THE DISTAL AREA. 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

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 41 MONTHS ARTIFACTS AND TWO INAPPROPRIATE SHOCKS WERE REPORTED. NO OTHER ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331770 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization