BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2054303 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01689
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EPISODE WHERE THEY KIND OF LOST CONSCIOUSNESS. IT WAS ALSO REPORTED THAT THE PATIENT HAD HIC COUGHS AND AT ONE TIME THE PATIENT FELT LIKE THEY WERE "KICKED" BY THE PACEMAKER. PATIENT REPORTED THEY ARE SEEING THE PHYSICIAN AND TESTING HAS BEEN DONE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R (B)(4) IMPLANTABLE PACING LEAD