BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 1924247 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13479
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    April 7, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD UNSUCCESSFULLY TREATED DFTS DUE TO PATIENT PHYSIOLOGY. ELEVATED DEFIBRILATION THRESHOLDS WERE OBSERVED. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBQ IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6996 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R