BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3952141 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13399
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 30, 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
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V515472, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V067514, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) LATER REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) ACCOMPANIED THE POWER ON RESET (POR). THE PATIENT HAD A RECENT VISIT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2014 WHEN THE THERAPY HAD STOPPED WORKING DUE TO AN UNCLEAR CAUSE. THE PATIENT HAD DIFFICULTY WALKING AND INCREASED RIGIDITY. AT A CLINIC VISIT ON (B)(6) 2014 THE PROGRAMMER INDICATED A BATTERY ERI AT 2.60 VOLTS, SO THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. THE INS WAS TURNED BACK ON AND THE PATIENT HAD ROUTINE FOLLOW-UP AT THE CLINIC. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ADJUST STIMULATION. THE DISPLAY WAS SHOWING A ¿CALL YOUR DOCTOR¿ ICON AND A POWER ON RESET (POR) CONDITION. AT THE TIME OF THE REPORT THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO NOT BEING ABLE TO WALK. THE PATIENT REPORTED HAVING DIFFICULTY WALKING THE NIGHT PRIOR TO THE REPORT AND WHEN HE CHECKED HIS PROGRAMMER HE HAD A ¿CALL YOUR DOCTOR¿ SYMBOL. WHEN THE HCP INTERROGATED THE IMPLANTABLE NEUROSTIMULATOR (INS) THE POR ERROR CODE WAS 0X400 THE FIRST TIME AND 0X0 THE SECOND. THE HCP DID NOT RECALL ANYTHING ¿UNUSUAL AROUND THE HOUSE¿ AND NO NEW EQUIPMENT NOR ANY MEDICAL PROCEDURE DONE. THE PATIENT DID LOOK AT A ¿BOX OF PAPER COPY PICTURES.¿ THE HCP NOTED THAT THE PATIENT DID CARRY A CELL PHONE AT THE BREAST POCKET OF HIS SHIRT, WHICH WAS THE SAME SIDE AS HIS INS. THE PATIENT¿S LAST OFFICE VISIT WAS ON (B)(6) 2014 AND HIS BATTERY VOLTAGE WAS 2.75 VOLTS. ON THE DAY OF THE REPORT IT WAS 2.65 VOLTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431397 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention