BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/16

    MDR report key: 3122311 · Received May 21, 2013

    Report

    Report Number
    1028232-2013-01498
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 17, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE 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 DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THIS WHOLE LEAD WAS CAPPED ON (B)(6) 2019 WHEN THE PATIENT WAS DOWNGRADED TO A PACEMAKER.

    Description of Event or Problem · 1

    NOISE RECORDED ON THE RV LEAD CAUSING MULTIPLE INAPPROPRIATE SHOCKS. NOISE WAS RECREATED WITH PROVOCATIVE LEFT ARM MOVEMENT. RECORDED NOISE COINCIDES WITH A SUDDEN AND RAPID DROP IN RV PACING IMPEDANCE. NO NOISE ON THE FARFIELD ELECTROGRAM AND SHOCK IMPEDANCE IS STABLE AND IN-RANGE. PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND A PACING LEAD WAS IMPLANTED. THE GENERATOR WAS CHANGED OUT AT THE TIME OF LEAD REVISION DUE TO BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224248 LINOX TD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization