BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3860544 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01168
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 FOLLOWING A DEVICE CHECK, THE PATIENT FELT PAIN CAUSED BY TWITCHING OF THE POCKET SITE. THE EXACT CAUSE WAS EVENTUALLY DETERMINED TO BE THAT THE PROGRAMMER EMERGENCY BUTTON HAD BEEN PUSHED INADVERTENTLY DURING THE DEVICE CHECK. 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
    341654 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDRS1

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR