BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 3152025 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08796
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    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: 5071 X2 IMPLANTABLE PACING LEADS, (B)(6) 2010. (B)(4). THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. THERE WAS A POWER ON RESET (POR). A CRITICAL RAM PARITY ERROR WAS RECORDED ON (B)(6) 2013. THE PARITY ERROR IS CONSIDERED LOW SEVERITY AND THE DEVICE SHOULD BE ABLE TO RECOVER AFTER RESET. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNDERGOING RADIATION THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET WAS OBSERVED ON THE REMOTE MONITORING TRANSMISSION. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNDERGOING RADIATION THERAPY. THE DEVICE WAS INTERROGATED AND 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
    253346 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention 4076 X2 IMPLANTABLE PACING LEADS