BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2130640 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03361
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 11, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 RECEIVED AN INAPPROPRIATE SHOCK. THE PATIENT HAD A VENTRICULAR FIBRILLATION (VF) THAT WAS TREATED WITH ANTI-TACHYCARDIA PACING (ATP), BUT FOLLOWING CHARGE END, THERE WAS T-WAVE OVERSENSING POST VENTRICULAR PACING WHICH LED TO THE INAPPROPRIATE SHOCK. THE DEVICE WAS CHANGED PARAMETER TO PREVENT SAFETY PACING. THE DEVICE REMAINS IN USE. 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 68 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD