BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3861541 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11182
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: 693565 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY BELIEVE THEY MAY HAVE RECEIVED A SHOCK. UPON FOLLOW UP, IT WAS DETERMINED THAT THE PATIENT HAD BEEN SEEN FOLLOWING THE INITIAL COMPLAINT AND HAD A DEVICE CHECK DONE AT THAT TIME. THE DEVICE INCORRECTLY DETECTED AN ATRIAL FIBRILLATION (AF) EPISODE AS A VENTRICULAR TACHYCARDIA (VT) EPISODE, RESULTING IN AN INAPPROPRIATE SHOCK TO THE PATIENT. THE PHYSICIAN ADJUSTED THE PATIENT'S MEDICATIONS, HOWEVER NO ADJUSTMENTS WERE MADE TO THE DEVICE AT THAT TIME. 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
    342753 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Life Threatening 383059 LEAD