BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2955640 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02451
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    August 29, 2012
    Report Date
    August 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 DEVICE'S CAPTURE MANAGEMENT TEST RESULTS VARIED FROM THE IN-OFFICE MANUAL TEST RESULTS. 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
    58269 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR 5076 X2 IMPLANTABLE PACING LEADS