BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4563842 · Received March 3, 2015

    Report

    Report Number
    3004209178-2015-03990
    Event Type
    Injury
    Date Received
    March 3, 2015
    Report Date
    February 8, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT FROM THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) SINCE (B)(6) 2013. WITHIN THE LAST YEAR, HE ALSO HAD TINGLING, A SHOCKING SENSATION IN THE BACK OF THE HEAD, ARM, AND ALL OVER THE BODY, AND A RUSHING FEELING IN HIS HEAD. TO TRY TO ADDRESS THIS, THE INS AND EXTENSION WERE CHANGED OUT DURING SEPARATE SURGERIES. THE REPORTER THOUGHT THE LEFT INS MAY HAVE BEEN REPLACED DUE TO A LOW BATTERY STATUS, BUT WAS NOT SURE. IT DID HELP SOME AS THE PATIENT ONLY HAD COUPLE OF THESE EVENTS SINCE REPLACEMENT. NO PATIENT OUTCOME WAS REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT #3004209178-2015-03977 AS THE PATIENT HAD ISSUES AFTER THE LEFT INS WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147061 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention