BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 2903925 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-03113
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 9 MONTHS, OVERSENSING OF THE RV LEAD WITH INAPPROPRIATE SHOCK DELIVERIES WAS REPORTED. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS EXPLANTED. THE DATE OF IMPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization