BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3990148 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01812
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. CONCOMITANT PRODUCT : A 4074-58 LEAD IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE DUE TO THE DEVICE MEASURING THE RIGHT VENTRICULAR THRESHOLD INCORRECTLY. THE VENTRICULAR CAPTURE MANAGEMENT (VCM) FEATURE MEASURED THE THRESHOLD AT 0.875 VOLTS (V) AND ADJUSTED THE OUTPUT TO 2 V, WHICH RESULTED IN NON-CAPTURE. WHEN THE THRESHOLD WAS MANUALLY MEASURED IN THE CLINIC, IT WAS 2.25 V AND THEN 1.75 V SO THE OUTPUT WAS REPROGRAMMED AND THE DEVICE WILL BE MONITORED CLOSELY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462948 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Life Threatening| R 4574-53 LEAD