BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 8666000 · Received June 4, 2019

    Report

    Report Number
    3004209178-2019-10796
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    June 1, 2018
    Report Date
    June 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169441873
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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) EXHIBITED AN ALERT FOR INAPPROPRIATE ELECTIVE REPLACEMENT INDICATOR (ERI) CONSISTENT WITH A KNOWN MEASUREMENT LOCK-UP CONDITION. THE IPG WAS 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
    462631 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDR01 00643169441873

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Required Intervention 5592-45 LEAD, 5092-52 LEAD