BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2203640 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01027
    Event Type
    Injury
    Date Received
    August 11, 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
    IL, US
    Reporter Occupation
    OTHER

    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 BY THE PATIENT THAT THE DEVICE HAS "MOVED DOWNWARD". PATIENT NOTED THEY ARE UNABLE TO RAISE ARM OVER THEIR HEAD DUE TO PAIN AND THE DEVICE AREA IS RED. THE PATIENT NOTED THINKING THEY HAD AN INFECTION BECAUSE THEY FEEL "CHILLS ALL THE TIME". FOLLOW-UP WITH THE CLINIC DETERMINED THE PATIENT HAS NOT BEEN SEEN SINCE PREVIOUS YEAR AND NO FURTHER INFORMATION WAS AVAILABLE. NO FURTHER PATIENT COMPLICATIONS WERE 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 53 YR Other 5076 X2 IMPLANTABLE PACING LEADS