BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2862429 · Received December 10, 2012

    Report

    Report Number
    6000153-2012-00241
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD FOUND THERE WAS CONDUCTOR CROSSOVER AT THE PROXIMAL END CONDUCTOR ON THE LEAD.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE LEAD REVEALED A SHORT BETWEEN CIRCUITS (DRY CONDITION) OF THE PROXIMAL END CONDUCTOR. FINAL DEVICE ANALYSIS FOR THE STYLET REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES WERE TESTED ON THE LEAD PRIOR TO IMPLANT. CONTACTS 0 AND 3 HAD IMPEDANCES OF 31 OHMS, INDICATING A SHORT CIRCUIT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA03X0T

    Patients

    Seq Age Sex Outcome Treatment
    1