BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5544945 · Received April 4, 2016

    Report

    Report Number
    3004209178-2016-05980
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    June 1, 2015
    Report Date
    April 4, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V951526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V951526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT WAS IMPLANTED WITH LEFT AND RIGHT VENTRALIS INTERMEDIUS (VIM) LEADS FOR ESSENTIAL TREMOR. SHE HAD ABNORMALITIES ON THE LEFT AND RIGHT SIDE IN JUNE 2015. THE LEFT SIDE CONCERNS WERE WITH ELECTRODE COMBINATIONS CASE <(>&<)> 8, CASE <(>&<)> 11, 8 <(>&<)> 9, 8 <(>&<)> 10, AND 8 <(>&<)> 11. THESE PAIRS ALL CAME UP IN THE OUT OF RANGE BOX AND WERE BETWEEN 1,700 AND 9 ,600 OHMS. THE PATIENT WAS PROGRAMMED ON CASE <(>&<)> 9 AND CASE <(>&<)> 10. ON THE RIGHT SIDE THE HCP STATED THAT IN JUNE 2015 THE ELECTRODE COMBINATIONS OF CASE <(>&<)> 2 AND CASE <(>&<)> 10 SHOWED UP IN THE OUT OF RANGE BOX. THEN IN (B)(6) 2015 ONLY CASE <(>&<)> 0 SHOWED UP IN THE OUT OF RANGE BOX. WHEN THE HCP RAN IMPEDANCES ON (B)(6) 2016 THERE WERE NO CONTACT PAIRS IN THE OUT OF RANGE BOX. THE IMPEDANCES RANGED FROM 1,200 TO 3,700 OHMS. THE THERAPY IMPEDANCES WERE WITHIN NORMAL RANGE. THE PATIENT WAS DOING FINE CLINICALLY AND RECEIVING INTENDED THERAPEUTIC BENEFIT. SHE WAS NOT ECSTATIC WITH THERAPY, BUT WAS NOT DISSATISFIED. THE PATIENT¿S INDICATIONS FOR USE WERE ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200803 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR