BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3142399 · Received June 3, 2013

    Report

    Report Number
    6000153-2013-00103
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE FIRST AND SECOND LEAD (LOT # VA07SQE) SHOWED THERE WAS A CONDUCTOR CROSSOVER AT THE PROXIMAL END.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, MODEL # 3389S-40, LOT VA07SQE, FOUND SHORT CIRCUITS OBSERVED ON CONDUCTOR #1 AND #3 AT OR NEAR CONNECTOR #3. THE CONDUCTOR INSULATION WAS BREACHED ON THE #1 AND THE #3 CONDUCTOR. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS. ANALYSIS OF THE TESTING CABLES, MODEL # 3550-68, LOT # N380104, FOUND NOT ANOMALIES. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # VA07SQE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3550-68, LOT # N380104, PRODUCT TYPE SCREENING; DEVICE PRODUCT ID 3550-68, LOT # N380104, PRODUCT TYPE SCREENING. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOW IMPEDANCES SEEN ON ELECTRODE PAIR 2 AND 3 (34 OHMS AT 3 VOLTS) ON ONE LEAD AND ELECTRODE PAIR 1 AND 3 (37 OHMS AT 3 VOLTS) ON THE SECOND LEAD. IT WAS STATED THAT DURING THE STAGE I PROCEDURE (ONLY LEAD IMPLANT) 1 LEAD WAS IMPLANTED IN THE RIGHT HEMISPHERE AND LOW IMPEDANCES WERE SEEN ON THE FIRST TWO IMPLANTED LEADS, THE THIRD HAD NO ISSUES. IT WAS FURTHER STATED THAT THE HEALTHCARE PROVIDER (HCP) WAS CONCERNED ABOUT HAVING BACK-TO-BACK SHORT CIRCUITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243283 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA07SQE

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR