BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 4162429 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19385
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: 5076-52, LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED THERAPY FOR DEVICE DETECTION CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD OBSERVED POTENTIAL FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD 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
    640387 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Life Threatening 694765 LEAD