BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 3151882 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01084
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC SMO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED POWER-ON RESET PARAMETERS WERE PRESENT. 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. THE PATIENT WAS EXPOSED TO RADIATION TREATMENT THERAPY. CONCOMITANT PRODUCT: 5076 X2 IMPLANTABLE PACING LEADS, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PARTIAL POWER ON RESET (POR) FOLLOWING RADIATION THERAPY. IT WAS REPROGRAMMED TO ORIGINAL SETTINGS. IT WAS ALSO REPORTED THAT THERE WAS A RAPID DECLINE IN BATTERY VOLTAGE THOUGHT TO BE DUE TO ACCUMULATED RADIATION FROM RADIATION THERAPY. 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
    252293 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SMO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention