BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3992287 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14871
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. CONCOMITANT PRODUCTS: 407652 LEAD, IMPLANTED 2008 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED INVALID/MISSING ATRIAL HIGH RATE (AHR) DIAGNOSTICS. DIAGNOSTICS MISMATCH WITH UNDER-REPORTING OF AT/AF WHICH IS CAUSING A HIGH NUMBER OF VENTRICULAR HIGH RATE EPISODES.

    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 THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE WAS UNDER REPORTING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) RESULTING IN A HIGH NUMBER OF VENTRICULAR HIGH RATE (VHR) EPISODES. THE DEVICE DIAGNOSTICS WAS NOT FILTERING OUT THE VHR EPISODES. IT WAS NOTED THAT AT/AF MODE SWITCH DIAGNOSTIC DATA WAS MISSING. 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
    467918 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR 5076-45 LEAD