BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2953657 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02036
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 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
    MX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED THREE MONTHS AFTER INITIAL IMPLANT WITH ATRIAL OVERSENSING, IT WAS DETERMINED THAT THE SETSCREW OF THE IMPLANTABLE PULSE GENERATOR (IPG)WAS NOT COMPLETELY TIGHTENED. THE DEVICE SET SCREWS WERE RETIGHTENED AND THE IPG 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
    55740 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR03

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R