BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3730880 · Received April 7, 2014

    Report

    Report Number
    3004209178-2014-05689
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Report Date
    March 18, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V025335, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0511362V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V025335, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387-40, LOT# J0511362V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V025335, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0511362V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE LEFT SUBTHALAMIC NUCLEUS (STN) HAD HIGHER THAN NORMAL IMPEDANCE READINGS. ELECTRODE IMPEDANCE WAS CHECKED AT 3V AND READINGS WERE C/0-9783 OHMS, 0/1-22399 OHMS, 0/2-23758 OHMS, 0/3-23580 OHMS. THE PATIENT WAS SEEN ON (B)(6) 2014 AND NO PARAMETER CHANGES WERE MADE. THE PATIENT WAS GOING WELL. THE PATIENT WAS PROGRAMMED WITH LEFT STN AT 3-C+, 3.2V, 60PW, 130HZ, THERAPY IMPEDANCE WAS 863 OHMS AND BATTERY VOLTAGE WAS 2.94V. RIGHT STN AT 2-C+, 3.3V, 60PW, 170HZ, THERAPY IMPEDANCE 685 OHMS AND BATTERY VOLTAGE WAS 2.86V. THE PATIENT WAS DOING OK BUT WAS FALLING A LOT. WHEN THE PATIENT WOULD REACH FOR THINGS HE WOULD FALL AND WHEN HE FELL WOULD LAND HEAD FIRST. THE FALLS OCCURRED ALL THE TIME AND THE PATIENT ALSO DID NOT SPEAK. THE PATIENT HAD NECK PAIN INJECTIONS, THE TIMEFRAME WAS UNKNOWN OF THE LAST INJECTION BUT HAD RECENTLY BEEN DONE. THE INJECTION WAS NOWHERE NEAR THE IMPLANTED SYSTEM AND TOWARDS THE BACK OF THE NECK. THE PATIENTLAST FALL WAS IN THE GARAGE AND PATIENT WEARS A LIFE ALERT; PATIENT HAD SET IT OFF WHEN HE LAST FELL. THE LAST FALL WAS A FEW DAYS PRIOR TO THE DATE OF THE OFFICE VISIT. THE PATIENT EXERCISED IN THE POOL A COUPLE OF TIMES A WEEK WHICH HELPED WITH MOBILITY. AN X-RAY OF THE LEAD, EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS) ON THE LEFT WAS GOING TO BE OBTAINED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED IMPEDANCE READINGS WERE GREATER THAN 2000 OHMS. THERE WERE HIGHER IMPEDANCE READINGS ON THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) SINCE APPOINTMENT IN (B)(6), ABOUT 2.5 MONTHS PRIOR TO THE DATE OF THIS REPORT. THERE WERE NO FALLS OR TRAUMAS AND THERE WAS NOTHING UNUSUAL. LEFT SIDE READINGS WERE C/0-11430 OHMS, 0/1 - 2059 OHMS, 0/2 - 5921 OHMS AND 0/3 5708 OHMS. PATIENT WAS NOT USING CONTACT 0 BUT MAY HAVE IN THE PAST BUT WAS NOT SURE. THE PATIENT WAS DOING WELL BUT HAD TROUBLE WITH SPEAKING FOR SOME TIME BUT HAD BEEN STABLE WHICH WAS DUE TO PARKINSON'S. AN X-RAY WOULD BE DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 3V FOR THE LEFT SUBTHALAMIC NUCLEUS IMPEDANCES WERE HIGH FOR C/0, 0/1, 0/2 AND 0/3. THE PATIENT WAS PROGRAMMED AT 3-C+, 3.5V, 60 PULSE WIDTH, 130 HZ, THERAPY IMPEDANCE WAS 1334 AND THE BATTERY VOLTAGE WAS AT 2.95V. IT WAS NOTED THAT THE PATIENT HAD BEEN FALLING ALL THE TIME. IT WAS FURTHER NOTED THAT PROBLEM HAD STARTED A WHILE AGO AND IT WAS UNKNOWN WHAT DATE THE FALLS HAD STARTED. ALL COMBINATIONS WITH 0 HAD APPEARED TO BE OUT OF RANGE AND POSSIBLE OPEN CIRCUITS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206322 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR