BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2950292 · Received February 8, 2013

    Report

    Report Number
    2649622-2013-00084
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PAUSES WERE NOTED ON A HOLTER MONITOR AND INTERROGATION SHOWED THERE WAS NO VENTRICULAR PACING. THE DEVICE 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
    54952 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention