BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2944152 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01314
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EROSION AT THE POCKET. THE REPORTER STATED THAT THIS APPEARED SEVERAL MONTHS AFTER THE IMPLANTABLE NEUROSTIMULATOR IMPLANTATION AND APPEARED TO BE EXTENSIVE LOSS OF ADIPOSE TISSUE AROUND THE DEVICE WITH SURROUNDING FIBROSIS. IT WAS REPORTED THAT THE DEVICE CAUSED DISCOMFORT AND THE PATIENT WAS "QUITE DISAPPOINTED" ABOUT THE APPEARANCE BUT VERY HAPPY ABOUT TREMOR CONTROL. THE REPORTER STATED THAT THE PATIENT WAS CONSIDERING FURTHER SURGERY FOR MILDER TREMOR ON THE OTHER SIDE, WHICH THE SURGEON WAS "LESS KEEN ABOUT." IT WAS NOTED THAT NO ACTION WAS TAKEN AND THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT. TWO WEEKS LATER, IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR HAD BEEN EXPLANTED. THE REPORTER STATED THAT THE DOCTOR PLANNED TO PUT A THERAPY SYSTEM ON THE OTHER SIDE AND PLANNED TO PUT IN A SUB-MUSCULAR DEVICE ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S PHYSICIAN WAS CONVINCED THE EVENT WAS DUE TO AN ALLERGY. HOWEVER, IT WAS NOTED THAT THE DEVICE HAD BEEN IMPLANTED FOR A YEAR AND THAT THE FIRST SIGNS OF THE PATIENT'S SYMPTOMS APPEARED SEVERAL MONTHS POST-OP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48914 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention