BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5410899 · Received February 4, 2016

    Report

    Report Number
    6000153-2016-00342
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 8, 2016
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387040, LOT# V212372, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 7489-51, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED VIA THE COMPANY REPRESENTATIVE (REP) THAT THE PATIENT WAS IMPLANTED WITH TWO IMPLANTABLE NEUROSTIMULATORS (INS) FOR BILATERAL DEEP BRAIN STIMULATION (DBS) THERAPY TO CONTROL PARKINSON'S DISEASE. THE NEUROLOGIST SUGGESTED A REVISION BEFORE THE INS BATTERIES DEPLETED BECAUSE THE PATIENT BENEFITED WITH THE GROUPS OPTION OF THE DEVICE. THERE WAS DAMAGE ON THE LEAD COVERAGE AND EXPOSED WIRE ON THE LEAD'S THIRD POLE (LEFT LEAD). THERE WAS ALSO DAMAGE ON THE LEAD COVERAGE OF THE RIGHT LEAD. THE ISSUE WAS IDENTIFIED DURING THE SYSTEM REVISION. WHEN THE PHYSICIAN DISCONNECTED THE EXTENSION FOR THE NEW ONES TO CONNECT A RECHARGEABLE INS, IT WAS SEEN THAT THE EXTENSION BOOT WAS BROKEN AND THE SILK WAS TOO TIGHT IN THE LEAD. WHEN THE PHYSICIAN CUT THE SILK AND TRIED TO CONNECT THE NEW EXTENSION, A LITTLE CABLE IN THE THIRD POLE OF THE LEAD WAS SEEN. IT WAS NOTED THAT BEFORE THE REVISION SURGERY, THE POLE IMPEDANCE WERE REVISED AND ALL THE THIRD POLES IMPEDANCE WERE HIGH: > 2,000 OHMS WITH 0 <(>&<)>C, 0<(>&<)>2, 0<(>&<)>3, 3<(>&<)>C, 1<(>&<)>3,2<(>&<)>3. IN ORDER TO BE ABLE TO CONNECT THE LEAD TO THE NEW EXTENSION, THE PHYSICIAN CUT THE WIRE AND CONTINUED WITH THE PROCEDURE. THE PHYSICIAN REPLACED THE OLD BOOT FOR A NEW ONE, HE JUST PUT A SILK ON THE EXTENSION SIDE OF THE CONNECTION, HE DIDN'T PUT THE SECOND SILK NEAR THE RIGHT LEAD. AFTER CONNECTION OF THE NEW EXTENSION WITH THE INS, IMPEDANCE PO LES WERE REVISED AGAIN, AND THE IMPEDANCES WERE FINE WITH THE RIGHT SIDE. AFTER CONNECTION OF THE NEW EXTENSION WITH THE INS, IMPEDANCE POLES WERE REVISED; THE IMPEDANCES WITH THE THIRD POLE WAS HIGH AGAIN ON THE LEFT SIDE. THE NEUROLOGIST WAS NOTIFIED AND HE AGREED TO KEEP WITH THE PROCEDURE BECAUSE HE DOESN'T USE THAT POLE FOR THE PATIENT'S DEEP BRAIN STIMULATION THERAPY. THE NEXT DAY THE NEUROSURGEON AND NEUROLOGIST CHECKED THE PATIENT. THE NEUROLOGIST PROGRAMMED THE PATIENT AS REQUIRED AND TOLD THE REP THAT THE PATIENT HAS A THERAPEUTIC BENEFIT WITH A PROGRAM THAT DOESN'T USE THE THIRD POLE IN THE LEFT LEAD: 0+, 1-, 180US, 130HZ. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68932 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387040 V433144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention