BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2920285 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00710
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3389-40, LOT# J0406022V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A RETURN OF TREMOR. IT WAS STATED THIS OCCURRED 5 DAYS PREVIOUS TO THE DATE OF THIS REPORT. NO FALLS OR TRAUMAS WERE REPORTED IN RELATION TO THIS COMPLAINT. IN ADDITION, NO MEDICAL TESTS OR PROCEDURES WERE REPORTED. ABOUT A WEEK LATER, AN END OF LIFE MESSAGE WAS REPORTED. IT WAS STATED THIS WAS "UNEXPECTED" SINCE THE LAST CHECK WAS IN (B)(6) AND THE BATTERY WAS AT 3.71V. THE BATTERY WAS ALSO AT 3.71V WHEN CHECKED IN (B)(6). IT WAS NOTED THE DEVICE HAD "ONLY LASTED 14 MONTHS." IT WAS INDICATED THE PATIENT WAS SENT TO THE HEALTHCARE PROVIDER FOR DEVICE REPLACEMENT. IT WAS UNCLEAR WHEN THE REPLACEMENT WOULD OCCUR. THE PATIENT'S CURRENT STIMULATION SETTINGS WERE REPORTED AS FOLLOWS: 4.6V, 120 PW, 185 HZ. THE ELECTRODES WERE PROGRAMMED AS 3-1-1+. IT WAS FURTHER NOTED THAT VOLTAGE HAD INCREASED SINCE 2010. A LONGEVITY CALCULATION WAS LATER COMPLETED USING THE ABOVE PARAMETERS. THE ESTIMATED LONGEVITY WAS "AROUND 9 MONTHS." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THERE WERE NO ABNORMAL IMPEDANCES, AND AFTER FURTHER INVESTIGATION THE BATTERY LIFE WAS DETERMINED TO HAVE BEEN AS EXPECTED FOR THE PATIENT'S SETTINGS. THE INS WAS REPLACED AND IT WAS REPORTED THAT THERE WAS NO HOSPITALIZATION AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25363 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention