BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2953414 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00229
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 28, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERROGATION OF THE DEVICE SHOWED THAT MODE SWITCH WAS INDICATED TO BE 50% IN ONE AREA OF THE DIAGNOSTIC DATA AND OTHER DIAGNOSTIC DATA SHOWED MODE SWITCH 100% OF THE TIME. REVIEW OF THE TREND AND HISTOGRAM DATA REVEALED THE PATIENT HAD CHRONIC ATRIAL FIBRILLATION (AF) AND BECAUSE OVER SIX MONTHS HAD PASSED SINCE INTERROGATIONS, THE ATRIAL HIGH RATE EPISODE PERCENT OF TIME WAS UNDERREPORTED BECAUSE OF THE LIMIT ON THE DEVICE'S DATA ACCUMULATION FOR PATIENT IN AF. 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
    55904 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1