BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4988135 · Received August 10, 2015

    Report

    Report Number
    3004209178-2015-15607
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 14, 2015
    Report Date
    April 13, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V931075, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V761180, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT, (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GROUP IMPEDANCES WERE HIGH ON THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). THE THERAPY IMPEDANCE VALUE OF THE ELECTRODE PAIR BEING USED BY THE PATIENT WAS 3596 OHMS. THE PATIENT'S SETTINGS WERE AS FOLLOWS: AMPLITUDE 2.3, PULSE WIDTH 180'S AND A RATE OF 140 HZ. LONGEVITY CALCULATION FOR ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS FOR THE INS WAS 7.17 YEARS AND TO END-OF-SERVICE (EOS) STATUS WAS 7.42 YEARS. THERE WERE NO PLANS TO REVISE OR CHANGE THE INS SYSTEM BASED ON THE IMPEDANCE FINDINGS. THE PATIENT WAS REPORTED AS GETTING GOOD THERAPY AND SYMPTOM CONTROL FROM THE INS. ADDITIONALLY, THE SETTINGS FOR THE CONCOMITANT INS SYSTEM IN THE PATIENT WAS AS FOLLOWS: AMPLITUDE 1.8 VOLTS, PULSE WIDTH 120, AND A RATE OF 185 HZ WITH A THERAPY IMPEDANCE OF 582 OHMS. THE BATTERY LONGEVITY CALCULATION FOR THIS DEVICE WAS 42 MONTHS. THE INDICATION FOR USE FOR THE DEVICE WAS NOTED AS PARKINSON'S DISEASE AND MOVEMENT DISORDER. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON 2017-04-04 ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT STILL HAS SOME IMPEDANCE ISSUES. THE IMPEDANCES FOUND WERE REPORTED TO BE OVER 4,000 OHMS ON A FEW GROUPS. IT WAS REPORTED THAT THE IMPEDANCES WERE ALSO FOUND IN (B)(6) 2016. THE PATIENT IS STILL GETTING SYMPTOM RELIEF FROM THE DEVICE.

    Description of Event or Problem · 1

    NO NEW INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521994 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR