BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3993104 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01923
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 OF THE DEVICE MEMORY INDICATED THE BATTERY MEASUREMENT WAS NOT AVAILABLE. IT WAS DETERMINED A FALSE ELECTIVE RE PLACEMENT INDICATION RESULTED FROM A MEASUREMENT SYSTEM LOCK UP. ADDITIONALLY, THE BATTERY VOLTAGE WAS NOT AVAILABLE DUE TO THE SYSTEM LOCK UP. RESETTING THE DEVICE THROUGH A PROGRAMMER WITH UPDATED SOFTWARE RECTIFIED THE LOCK UP PROBLEM.

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THE DEVICE DID NOT DISPLAY THE REMAINING BATTERY VOLTAGE AND DISPLAYED UNUSUAL PACING IMPEDANCE TRENDS. IT WAS DETERMINED THAT THE DEVICE MEASUREMENT SYSTEM HAD LOCKED UP, RESULTING IN A FALSE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGER. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED AND 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
    468676 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention