BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3840877 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09904
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# VA0BBQP, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# VA0BBQP, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ¿CORDS¿ WERE TOO TIGHT SO AT THE REVISION ON (B)(6) 2014 THE HEALTHCARE PROFESSIONAL (HCP) HAD TRIED TO LOOSEN THEM UP IN HER NECK BUT THE HCP THOUGHT THERE WAS TOO MUCH SCAR TISSUE AND IT HAD NOT HELPED. PATIENT WAS TOLD THEY WOULD ASSESS THIS AGAIN IN 3 MONTHS FROM THE DATE OF THIS REPORT AND AT THAT TIME THERE MAY BE A NEED TO DO ANOTHER SURGERY TO REVISE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318532 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention