BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4362608 · Received December 26, 2014

    Report

    Report Number
    3004209178-2014-24529
    Event Type
    Malfunction
    Date Received
    December 26, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V050681, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V451314, IMPLANTED: (B)(6) 2010, 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. PRODUCT ID: 3389S-40, LOT# V348020, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V050681, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389S-40, LOT# V348020, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 5AM ON THE DAY PRIOR TO THE DATE OF THIS REPORT, THE PATIENT HAD FELT LIKE THE DEVICE MIGHT BE AT END OF SERVICE (EOS). THERE WAS A ¿DYSTONIC STORM¿ WHERE THE PATIENT HAD HAD TINGLING AND ITCHING AT THE TOP OF THE SCALP AND INSIDE THE HEAD. THERE WAS ITCHING WAY INSIDE THE EAR. THE PATIENT STATED ¿THE LEADS WERE PUT TOO FAR IN AND THE HEALTHCARE PROFESSIONAL WAS AFRAID TO MOVE THE LEAD.¿ THE DEVICE WAS FUNCTIONING JUST FINE AND THE PATIENT HAD ALSO STATED THAT THE DEVICE WAS NOT DOING ANYTHING FOR HER MEDICALLY. CROSS TALK WAS A MENTIONED POSSIBILITY SINCE THE PATIENT HAD TWO DEVICES. THE DYSTONIA WAS ON THE LEFT SIDE. THE PATIENT HAD BEEN SLEEPING AT 5AM ON THE DAY PRIOR TO THE DATE OF THIS REPORT. THERE WERE NO FALLS OR TRAUMAS REPORTED. THE RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE WAS 2.795 VOLTS, ELECTIVE REPLACEMENT INDICATOR (ERI) WOULD HAPPEN AT 2.6VOLTS, THERAPY IMPEDANCE WAS 840 OHMS, 18.22MA AND 832 OHMS, 2.979MA. RIGHT SIDE SETTINGS WERE C+ -6, 2V, 60PW, 100 HERTZ WITH A 4 SECOND SOFT START. THE LEFT SIDE DEVICE WAS INTERROGATED AND SETTINGS WERE C+-2, 2V, 60 PW AND 100 HERTZ. THE LAST RESET WAS (B)(6) 2014. IT WAS USED 2% IN THE LAST 24 HOURS AND THE BATTERY WAS OK. 3.06 VOLTS FOR THE BATTERY WAS A USED CAPACITY OF <(><<)> 20%. THERAPY IMPEDANCES WERE OVER 4000 OHMS, LESS THAN 15MA. ELECTRODE IMPEDANCES WERE RUN AT 1.5V AND THE VALUES WERE 0/C-1395, 1/C-1395, 2/C-1395, 3/C->4000, 0/1-690, 0/2-1395, 0/3-1395, 1/2-690, 1/3-1395, AND 2/3-1395. 4/C, 5/C, 6/C AND 7/C WERE ALL GREATER THAN 4000 OHMS, 4/5-1395, 4/6-1395, 4/7->4000, 5/6-1395, 5/7->4000 AND 6/7 -1395 OHMS. IMPEDANCES WERE RE-RUN AT 2V TO GET MORE ACCURATE READINGS. ELECTRODE IMPEDANCES WERE 0/C->4000, 1/C-1868, 2/C->4000, 3/C->4000, 0/1-928, 0/2-1868, 0/3-1868, 1/2-928, 1/3-928, 2/3-928. 4/C->4000, 5/C->4000, 6/C->4000, 7/C->4000, 4/5-1868, 4/6-1868, 4/7-1868, 5/6-1868, 5/7-1868, AND 6/7-1868 OHMS. A PRINTOUT FROM (B)(6) 2014 WAS SEEN AND IT HAD NOT HAD ANY IMPEDANCES BUT HAD NOTED THE SETTINGS WERE THE SAME AS THEY WERE AT THE TIME OF THIS CALL. NO INTERVENTION OR OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-24528.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852645 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR