BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA DR

    MDR report key: 3863211 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10989
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCTS: 694765 LEAD, IMPLANTED: (B)(6) 2004; D334DRG ICD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT TRIGGERED FOR HIGH IMPEDANCE ON THE RV AND SVC COILS. THE LEAD REMAINS IN USE AND WILL BE FURTHER EVALUATED. IT WAS ALSO NOTED THAT THE DEVICE HAD BEEN IMPLANTED AFTER THE USE-BY-DATE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339129 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR 5076-58 LEAD