BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3994289 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14931
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 23, 2014
    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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7482A95, SERIAL# (B)(4) IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A95, SERIAL# (B)(4) IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387-40, LOT# J0527189V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S BODY APPEARED TO HAVE ¿METABOLIZED¿ THE LEAD INSULATION. THE LEAD INSULATION WORE AWAY EXPOSING METAL AND CAUSING A SKIN REACTION, EROSION, AND SKIN LESIONS. THE PATIENT HAD SYMPTOMS OF EROSION, REDNESS, AND A POTENTIAL TITANIUM ALLERGY, BUT THE ALLERGY WAS NOT CONFIRMED. THE LEAD WAS BROKEN OR FRACTURED AND THE DAMAGE WAS DETECTED WHEN REMOVING THE LEAD. THE LEAD WAS SCARRED INTO THE SKULL SO THE LEAD WAS CUT ABOVE THE BURR HOLE AND COVERED WITH BONE CEMENT. THE CAUSE OF THE EVENT WAS DETERMINED TO BE A REACTION TO THE COMPONENTS. THE PATIENT WAS RECOVERING FROM THE EXPLANT OF THE LEADS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED DUE TO THE INS MOVING IN THE BODY. THEY HAD THE INS REMOVED AND WOULD SOON HAVE THE LEADS REMOVED AS WELL. THE DOCTOR WANTED TO DO AN MRI TO MAP EXACTLY WHERE THE LEADS WERE IN THE BRAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING, SKIN EROSION, AND POTENTIAL ALLERGIC REACTION AT THE DEVICE POCKET AND LEAD LOCATION, AS WELL AS INFECTION WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE SKIN EROSION WAS DUE TO AN UNDETERMINED CAUSE. THE INS WAS EXPLANTED ON DAY OF REPORT, AND THE PATIENT REQUIRED HOSPITALIZATION AND MEDICATION. THE PATIENT WAS ALIVE, WITH INJURY, AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE SKIN EROSION WAS A SUSPECTED METAL ALLERGY. A CULTURE WAS TAKEN FROM THE POCKET TISSUE. THE TYPE OF ORGANISM CULTURED AND MEDICATION THAT WAS ADMINISTERED WERE UNKNOWN. THE PATIENT WAS RECOVERING, BUT IT WAS UNDETERMINED IF THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468668 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R