BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3993884 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14569
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 MEDICAL PRODUCTS: 4261 COMPETITOR LEAD, IMPLANTED (B)(6) 1994. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK OF THE IMPLANTABLE PULSE GENERATOR (IPG) AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE WAS OBSERVED. THE PHYSICIAN THEN REVIEWED THE INTERROGATION REPORT WHICH INDICATED THAT THE LONGEVITY ESTIMATE FOR THE DEVICE WAS SEVEN TO EIGHT YEARS. IT WAS DETERMINED THAT A DEVICE ELECTRICAL RESET HAD LIKELY OCCURRED. 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
    470208 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR 4269 COMPETITOR LEAD