BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2951910 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01641
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 19, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY : THE SAVE TO DISK OF THE DEVICE WAS REVIEWED. IT REAVEALED THERE WAS ONE POWER ON RESET (POR) FOR CRITICAL RAM PARITY ERROR LOGGED ON (B)(6) 2012. POR SEVERITY IS CONSIDERED LOW AS DEVICE SHOULD BE ABLE TO RECOVER FULLY AFTER RESET. CONCOMITANT PRODUCT: COMPETITOR 1782TC IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, IT WAS FOUND THAT THE DEVICE WAS PACING AT VVI 65 BUT HAD NOT REACHED THE RECOMMENDED REPLACEMENT TIME. IT WAS ALSO REPORTED THAT A POWER ON RESET HAD OCCURRED. THE DEVICE WAS REPROGRAMMED 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
    56096 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention 4076 IMPLANTABLE PACING LEAD