BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM II VR

    MDR report key: 2810691 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03722
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 21, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S3
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "MARKED ATTENUATION OF SHOCK BURDEN: BY THE USE OF ANTITACHYCARDIA PACING THERAPY IN A PATIENT WITH AN IMPLANTED CARDIOVERTER-DEFIBRILLATOR." TEX. HEART INST. J. (B)(4) 2012; 39(4):568-570.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE. THE PATIENT PRESENTED AFTER RECEIVING "REPEATED [IMPLANTABLE CARDIOVERTER DEFIBRILLATOR] ICD SHOCKS" FOR ONE EPISODE OF TACHYCARDIA. THE TACHYCARDIA COULD NOT BE REPRODUCED DURING A (B)(4) STUDY. MEDICATION THERAPY WAS INITIATED. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. 7229CX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R