BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 3152251 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01074
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    June 20, 2012
    Report Date
    March 5, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THAT THE DEVICE WAS SET TO POWER ON RESET PARAMETERS. IT WAS NOTED THAT THERE WAS A CRITICAL RAM PARITY ERROR RECORDED ON 2012 (B)(4) AND THAT THE PARITY ERROR IS CONSIDERED TO BE LOW SEVERITY AND THE DEVICE SHOULD BE ABLE TO RECOVER AFTER THE RESET.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED FOR SCHEDULED FOLLOW-UP AND IT WAS FOUND A POWER-ON-RESET (POR) FOR THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE HAD OCCURRED OVER EIGHT MONTHS EARLIER. THE DEVICE SOFTWARE WAS REVISED WITH THE NORMAL INTERROGATION FOLLOW-UP PROCESS. A LOSS OF THE TRENDING DATA FOR BATTERY VOLTAGE AND BATTERY IMPEDANCE WAS NOTED. NO PRODUCT PERFORMANCE ISSUE IS ALLEGED REGARDING PATIENT CARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252403 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention