BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 3232157 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01931
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 4, 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

    THE LEAD UNDER COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR LEAD. THE MANUFACTURING PROCESS FOR THIS LEAD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE ERI BATTERY STATUS WAS ANTICIPATED. THE LEAD UNDER COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR LEAD MANUFACTURING. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN ESTIMATED IMPLANT DURATION OF 2 YEARS OVERSENSING WITH 57 INAPPROPRIATE SHOCKS WAS REPORTED. THE ICD WAS EXPLANTED DUE BATTERY DEPLETION AND RECEIVED FOR ANALYSIS. THE LEAD COULD NOT BE EXPLANTED. NO IMPLANT OR EXPLANT DATES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330783 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization