BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1992476 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00186
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE U.S. 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. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: "MANAGED VENTRICULAR PACING ALGORITHM DURING BRADY- AND TACHYARRHYTHMIA." HEART RHYTHM SOCIETY. NOVEMBER 1;7(11):1632-1634.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS DEVICE. IT WAS REPORTED THAT THE PATIENT FELT A "GRADUAL SYMPTOMATIC DETERIORATION" OVER A FEW MONTHS. HE WAS ASSESSED FOR HEART TRANSPLANTATION. DEVICE MONITORING AND INTERROGATION DURING HOSPITALIZATION SHOWED "ASYNCHRONOUS PACING ARTIFACT." ALSO NOTED WAS THAT THE DEVICE WAS UNDERSENSING. DEVICE STATUS IS UNKNOWN. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. ICD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| O| R