BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 2933117 · Received January 23, 2013

    Report

    Report Number
    1028232-2013-00124
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    MOMENTARY NOISE SEEN ON FF AND RV LEAD. INAPPROPRIATE VF DETECTIONS SEEN WITH NO INAPPROPRIATE THERAPY DELIVERED. ALL LEAD DIAGNOSTICS WITHIN RANGE AND STABLE. UNABLE TO REPRODUCE NOISE AT FOLLOW-UP WITH PROVOCATIVE MANEUVERS. POSSIBLE EMI. WILL CONTINUE TO MONITOR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33229 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other