BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2954470 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02394
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE RESPONSE WAS PROGRAMMED TO AGGRESSIVE FOR THE PATIENT AS THE PATIENT WAS HAVING PALPATIONS WITH ACTIVITY. THE DEVICE WAS PROGRAMMED LESS AGGRESSIVE 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
    59301 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRS1

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention 4076 X2 IMPLANTABLE PACING LEADS