BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1926344 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02314
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCE SYNCOPAL EPISODES, THERE WAS HIGH AND VARYING IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. THE SETSCREWS WERE ADJUSTED IN A REVISION. THE DEVICE REMAINS 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 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7298 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R