BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3061065 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06335
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    April 1, 2013
    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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3387-40, LOT# L74012, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: LEAD: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387-40, LOT# L74116, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: LEAD: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000. PRODUCT TYPE: EXTENSION: PRODUCT ID 7438, SERIAL# (B)(6), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERAPY IMPEDANCE WAS 64 OHMS. ALL MONO-POLARS WERE IN THE 300¿S. ALL BIPOLAR PAIRS WERE LESS THAN 50 OHMS. THE HEALTH CARE PROFESSIONAL WAS UNSURE OF WHEN THIS HAPPENED BUT IT WAS NOTED IN BETWEEN THE PATIENT¿S APPOINTMENT IN DECEMBER AND THEIR LAST VISIT A FEW WEEKS PRIOR TO REPORT. PATIENT HAD A RETURN OF DYSKINESIAS. REFER TO MANUFACTURER REPORT NUMBER FOR REPORT ON THE PATIENT¿S OTHER DEVICE. IT WAS UNCLEAR WHICH DEVICE HAD LOW IMPEDANCES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163705 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1