BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3103640 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07483
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 24, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA04RP2, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# VA04RP2, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# VA04RP2, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE HAD NOT BEEN RESOLVED AND THE PATIENT HAD NOT BEEN REPROGRAMMED. AN APPOINTMENT TO GET THE PATIENT REPROGRAMMED WAS "STILL BEING ARRANGED". TWO WEEKS LATER IT WAS REPORTED THAT THERE WERE NO NEW UPDATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EXPERIENCE OF A SUDDEN FULL RETURN OF HIS HAND TREMOR JUST LIKE PRIOR TO THE IMPLANT AND SOME HEAD TREMOR BEGINNING IN THE MORNING ONE DAY PRIOR TO THE REPORT. IT WAS STATED THAT THE PATIENT USUALLY TURNED HIS IMPLANTABLE NEUROSTIMULATOR (INS) OFF AT NIGHT AND BACK ON IN THE MORNING. THE PATIENT WAS LAST SEEN BY HIS HEALTHCARE PROFESSIONAL (HCP) ALMOST THREE WEEKS PRIOR TO THE REPORT AND ALL WAS GOOD AT THE CONCLUSION OF THAT APPOINTMENT AND "BOTH HANDS WERE JUST AS STEADY AS THEY COULD BE, NOTHING WAS MOVING." IT WAS REPORTED THAT, USING PATIENT PROGRAMMER, THE IMPEDANCES WERE FOUND TO BE GOOD, NO OPEN CIRCUITS WERE DETECTED, NO BROKEN WIRES WERE NOTED. HOWEVER, IT WAS NOT POSSIBLE TO DETECT SHORT CIRCUITS WITH THE PROGRAMMER. PATIENT'S PARAMETERS WERE 5.5 V ON THE LEFT AND 4.5 V ON THE RIGHT. IT WAS STATED THAT THE PATIENT ALSO HAD A PROGRAM B BUT PATIENT'S HCP WAS GOING TO BE CONTACTED FOR INSTRUCTION FIRST BEFORE USING THAT PROGRAM. TWO DAYS LATER IT WAS REPORTED THAT THE CAUSE OF THE EVENT HAD NOT BEEN DETERMINED. IT WAS STATED THAT THE PATIENT HAD AN APPOINTMENT TO BE SEEN THE WEEK AFTER THE REPORT. IT WAS NOT KNOWN IF ANY INTERVENTIONS HAD BEEN TAKEN AND THE PATIENT OUTCOME WAS UNKNOWN. FIVE DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS SEEN ONE DAY PRIOR TO THE REPORT BY THE HCP. READING LOW OUT OF RANGE IMPEDANCE VALUES WAS REPORTED. THERAPY IMPEDANCE WAS 88 OHMS, ELECTRODE IMPEDANCE WAS NORMAL EXCEPT FOR ELECTRODES 8 AND 9 AT 38 OHMS. THE INS WAS PROGRAMMED TO 8- 9+. IT WAS ALSO REPORTED THAT THE BATTERY HAD BEEN INTERROGATED ONE DAY PRIOR TO THE REPORT. THERE RESULTS WERE: CURRENT SETTINGS: L VIM, 4.5 V, 70 US, 180 HZ R VIM, 5.5 V, 80 US, 180 HZ THERAPY IMPEDANCE: L VIM, 1161 OHMS, 3.892 MA R VIM, 88 OHMS, "HIGH" AMPERAGE RIGHT ELECTRODE IMPEDANCE: C <(>&<)> 8, 1068 OHMS C <(>&<)> 9, 1068 OHMS C <(>&<)> 10, 1865 OHMS C <(>&<)> 11, 1904 OHMS 8 <(>&<)> 9, 38 OHMS 8 <(>&<)> 10, 2598 OHMS 8 <(>&<)> 11, 2743 OHMS 9 <(>&<)> 10, 2598 OHMS 9 <(>&<)> 11, 2743 OHMS 10 <(>&<)> 11, 3477 OHMS LEFT ELECTRODE IMPEDANCE: C <(>&<)> 0, 909 OHMS C <(>&<)> 1, 836 OHMS C <(>&<)> 2, 1483 OHMS C <(>&<)> 3, 1507 OHMS 0 <(>&<)> 1, 1145 OHMS 0 <(>&<)> 2, 1904 OHMS 0 <(>&<)> 3, 1992 OHMS 1 <(>&<)> 2, 1641 OHMS 1 <(>&<)> 3, 1879 OHMS 2 <(>&<)> 3, 2113 OHMS IT WAS STATED THAT THE PATIENT'S VOLTAGE ON THE RIGHT HEMISPHERE WAS TURNED TO 0.0 V BY THE HCP UNTIL THE PATIENT COULD BE REPROGRAMMED BY A MOVEMENT DISORDERS SPECIALIST. BATTERY VOLTAGE WAS AT 2.73 V ROUGHLY ONE MONTH POST IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203787 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1