BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2203773 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04217
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PATIENT WAS EXERCISING AND RECEIVED AN INAPPROPRIATE SHOCK DUE TO A SINUS TACHYCARDIA WHICH THE DEVICE IDENTIFIED AS VENTRICULAR TACHYCARDIA. THE DEVICE REMAINS IN USE. FOLLOW-UP WITH THE CLINIC DETERMINED THAT THE PATIENT'S BETA BLOCKER WAS INCREASED AND PATIENT WAS STARTED ON ANOTHER MEDICATION. NO FURTHER SHOCKS HAVE BEEN RECEIVED SINCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD