BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3307761 · Received August 26, 2013

    Report

    Report Number
    3004209178-2013-15124
    Event Type
    Injury
    Date Received
    August 26, 2013
    Date of Event
    July 28, 2013
    Report Date
    July 29, 2013
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 7436, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT # 227180002, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3387S-40, LOT # V031488, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V031488, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WENT THROUGH A SECURITY GATE AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF ONCE THE PATIENT PASSED THROUGH THE GATES. IT WAS NOTED THE SOURCE OF EXPOSURE WAS FROM A SECURITY GATE. IT WAS FURTHER NOTED THE PATIENT DID NOT HAVE THEIR PATIENT PROGRAMMER AND A MANUFACTURING REPRESENTATIVE WAS PAGED TO ASSIST IN TURNING STIMULATION BACK ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET (POR) WAS OBSERVED ON THE RECHARGER. THE PATIENT LAST CHARGED TWO DAYS PRIOR TO THIS REPORT. THE PATIENT WAS ABLE TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) TO CHARGE AND THE RECHARGER INDICATED THE BATTERY WAS ¾ FULL. THE PATIENT¿S THERAPY WAS OFF. THE PATIENT WENT THROUGH AIRPORT SECURITY ONE DAY PRIOR TO REPORT AND SUSPECTED THAT THE DEVICE WAS SHUT OFF BY A SECURITY SCREENER. THE PATIENT WAS NOT ABLE TO TURN THE THERAPY ON BECAUSE THE PROGRAMMER WAS NOT WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS TRAVELLING AND FORGOT THE PATIENT PROGRAMMER AND DID NOT WANT TO BE ADMITTED TO THE HOSPITAL TO TURN ON THE DEVICE. THE PATIENT COULD NOT TURN THE DEVICE ON WITH THE RECHARGER AS THAT ABILITY HAD BEEN PURPOSELY DISABLED FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM AS THE PATIENTS SYMPTOMS HAD RETURNED. THE SYMPTOMS INCLUDED BILATERAL DYSTONIA GPI. THE POR WAS CLEARED AND THE STIMULATOR WAS TURNED BACK ON. THE POR WAS A 0X400. THE TIME SETTINGS WERE VERIFIED. IT WAS NOTED THAT THE PATIENT HAD GONE THROUGH SECURITY SCREENERS BEFORE WITHOUT ISSUE. THE PATIENT DID NOT NOTICE A RETURN OF SYMPTOMS IMMEDIATELY AFTER GOING THROUGH AND THOUGHT IT WAS A ¿WEARING OFF EFFECT.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ELECTROMAGNETIC INTERFACE (EMI) EVENT HAD NOT BEEN CONFIRMED. IT WAS NOTED THAT IT WAS SPECULATED BY THE PATIENT. DIAGNOSTICS INCLUDED CONDUCTING THERAPY AND ELECTRODE IMPEDANCE MEASUREMENTS AND THEY DEMONSTRATED ¿SOME¿ OPEN CIRCUITS. IT WAS UNKNOWN IF IT HAD BEEN THAT WAY FOR ¿A WHILE.¿ THERAPY IMPEDANCE DEMONSTRATED A GOOD SYSTEM. INTERVENTIONS INCLUDED ASSISTING THE PATIENT WITH THE POR. IT WAS NOTED THAT THE THERAPY DID NOT DEMONSTRATE EFFICACY IMMEDIATELY BUT IT COULD TAKE UPWARDS OF 12-48 HOURS TO CONFIRM EFFICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415194 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization