BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 4834078 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11127
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    February 20, 2015
    Report Date
    April 23, 2015
    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
    WA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS, WHICH APPEARED TO BE INAPPROPRIATE. THERE WAS AN EPISODE THAT CONSISTED OF THREE ROUNDS OF ANTI-TACHYCARDIA PACING (ATP), THEN SHOCKS WERE DELIVERED. THERE WAS POTENTIAL RAPID VENTRICULAR RESPONSE (RVR). IT WAS SUSPECTED THAT THE DISCRIMINATOR FAILED TO WITHHOLD THERAPY AND WAS NOT APPLIED. ALSO, THE LEAD POSITION CHECK HAD FAILED ON THE RIGHT ATRIAL (RA) LEAD AND THE AT/AF THERAPIES WERE DISABLED. THE DEVICE AND LEAD REMAIN 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
    373440 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Life Threatening 694765 LEAD, 5076-52 LEAD