BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3881021 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11748
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2014-(B)(60,) PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387-40, LOT# V003289, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3387-40, LOT# V003289, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# V003289, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THERE WAS AN END OF SERVICE (EOS) MESSAGE. THE INS WAS REPLACED ON THE DATE OF THIS REPORT DUE TO BEING AT EOS. IT WAS NOTED THAT THIS WAS NORMAL BATTERY DEPLETION AND THERE WERE NO BATTERY LONGEVITY CONCERNS. THERE WERE LOW OUT OF RANGE IMPEDANCE VALUES ON THE DATE OF THIS REPORT AFTER THE INS WAS CHANGED OUT. IT WAS NOTED THAT PAIR 1-3 WAS 28 OHMS, WHICH WAS A SHORT. THE PATIENT SETTINGS WERE 3.5V, 60US, 180HZ. IMPEDANCES WERE MEASURED IN (B)(6) 2013 AND 1-3 WAS 1413 WITH PREVIOUS DEVICE SO THE SHORT HAD OCCURRED BETWEEN (B)(6) 2013 AND THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-11747.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS, RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) 1 AND 3 WERE 28. IMPEDANCES RESOLVED, THEY WERE CHECKED POST-OPERATIVE IN RECOVERY ROOM. THE CAUSE OF THE IMPEDANCE ISSUE WAS NOT DETERMINED, IT WAS POSSIBLE THERE WAS FLUID AT THE BATTERY SITE. IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THERE WERE NO LEAD FRACTURES NOTED. PROGRAMMING WAS CHANGED TO USE C+1-. BATTERY WAS DEPLETED DUE TO NORMAL EXPECTED DEPLETION. PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357387 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR