BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3267484 · Received August 6, 2013

    Report

    Report Number
    3004209178-2013-12870
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Report Date
    July 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE. NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V014617, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V067936, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DOCTOR WAS POSSIBLY GOING TO REFER TO A SURGEON TO REDO THE LEADS DUE TO THE PATIENT LOSING SOME THERAPY BENEFIT; HOWEVER, IT HAD NOT BEEN CONFIRMED IF THE SURGEON WILL REDO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S THERAPY IMPEDANCE WAS ¿> 2010, 43.¿ IT WAS NOTED THE HIGH IMPEDANCE DID NOT RESOLVE AFTER IMPLANT. IT WAS FURTHER NOTED THE HEALTHCARE PROFESSIONAL WOULD FOLLOW UP WITH THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS GETTING THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR. REPORT # 3004209178-2013-12869. IT WAS UNCLEAR WHICH DEVICE HAD HIGH IMPEDANCE, OR IF BOTH DEVICES HAD HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367396 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR