BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3896994 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12092
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 6, 2014
    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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# V336928, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V345141, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD, PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LIFE, LEFT SHOWED AT 3.3V, 60US, 170, 766 OHMS = 52 MONTHS. LEFT INS PAST VOLTAGES HAD ALL BEEN AT 3.69V IN (B)(6) 2014 VISITS. THE RIGHT INS AT 3.5V, 60US, 160 HZ AND 1260 OHMS = 69 MONTHS. PATIENT FELT LIKE THE DEEP BRAIN STIMULATOR WAS NOT WORKING ANYMORE AND MAY NEED TO BE REPLACED. NO SYMPTOMS WERE REPORTED. THE PATIENT HAD NOT BEEN SEEN IN THE CLINIC YET. IT WAS UNKNOWN WHEN THE ISSUE STARTED WITH THE THERAPY NOT WORKING. THE PATIENT¿S HEALTHCARE PROFESSIONAL WAS LOOKING INTO DISCUSSING REPLACEMENTS AT THE PATIENT¿S NEXT VISIT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374867 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1