BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 3151936 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08803
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 27, 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
    WI, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. POWER ON RESET PARAMETERS WERE OBSERVED. A CRITICAL RAM PARITY ERROR WAS RECORDED ON (B)(6) 2013. PARITY ERROR IS CONSIDERED LOW SEVERITY AND THE DEVICE SHOULD BE ABLE TO RECOVER AFTER RESET. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2007 X 2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET (POR) WITH FULL RESET SETTINGS. THE PATIENT DENIED ANY MEDICAL PROCEDURES OR ANY ELECTRO MAGNETIC INTERFERENCE SOURCES KNOWN. THE DEVICE IS STILL 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
    252548 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention