BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4660165 · Received April 6, 2015

    Report

    Report Number
    3004209178-2015-05976
    Event Type
    Injury
    Date Received
    April 6, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V149879, IMPLANTED: 2009-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V053074, IMPLANTED: 2009-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 7482A66, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A66, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOW IMPEDANCE OF 57 ON 0 AND 3 ELECTRODE PAIR WHICH THE PATIENT HAD BEEN USING WHICH WAS LIKELY A SHORT. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEVERE RETURN OF TREMOR ON THE RIGHT SIDE. DIAGNOSTIC TESTING INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. THE PATIENT WAS SWITCHED FROM 0+, 3- TO C+, 3- AND THE TREMOR RESOLVED COMPLETELY. THE AMPLITUDE WAS DROPPED FROM 3.5 VOLTS TO 2.0 VOLTS AND THE BATTERY READING WAS 2.67 AND WOULD SOON NEED TO BE REPLACED. THE ISSUE WAS RESOLVED BUT THE CAUSE WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225886 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization