BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3160428 · Received June 10, 2013

    Report

    Report Number
    9614453-2013-01419
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REDACTING REPORT: FOLLOW UP CONFIRMED THE PATIENT WAS SEEN IN THE CLINIC AND PACEMAKER WAS FINE. IT WAS DETERMINED THERE WAS NO POWER ON RESET (POR) AND NO MALFUNCTION ON THE DEVICE. THE ISSUE WAS WITH THE REMOTE MONITOR WHICH WAS NOT WORKING PROPERLY. PER OUR CURRENT REPORTABILITY MATRIX, THIS IS NOT A RESULT OF THE MONITOR TO FAIL TO MEET ITS PERFORMANCE SPECIFICATION OR PERFORM ITS ESSENTIAL FUNCTION. THERE WAS NO REPORT OF A PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSMISSION INDICATED ALL ZEROS FOR THE DEVICE SERIAL NUMBER, INDICATING A POWER ON RESET (POR) HAD OCCURRED ON THE DEVICE. FOLLOW UP CONFIRMED THE PATIENT WAS SEEN IN THE CLINIC AND "THE PACEMAKER WAS TOTALLY FINE. THE PROBLEM CAME FROM THE REMOTE MONITOR WHICH WAS NOT WORKING." THE STATUS OF THE MONITOR IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSMISSION INDICATED ALL ZEROS FOR THE DEVICE SERIAL NUMBER, INDICATING A POWER ON RESET (POR) HAD OCCURRED ON THE DEVICE. THE DEVICE 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
    259334 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1