BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2892221 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00014
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 10, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387-40, LOT# V001355, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 3387-40, LOT# J0102029V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY, THE STIMULATOR INS WAS NOT IN NEW CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DEVICES DID NOT DELIVER THE EXPECTED TREMOR CONTROL "ALMOST THE WHOLE TIME" THE PATIENT HAD THEM. THE REPORTER STATED THAT THE DEVICES WERE REPLACED BECAUSE ONE WAS DEPLETED AND THE OTHER WAS WEAK. IT WAS REPORTED THAT THE PATIENT HAD A SERIOUS ACCIDENT IN (B)(6) 2012 AND LOST HIS (B)(6) JOB "DUE IN PART TO EXCESSIVE TREMOR". THE REPORTER STATED THAT WHEN THE PATIENT WENT TO DOCTORS FOR HELP AND ANSWERS, THE STANDARD ANSWER WAS "THE BATTERIES STILL HAD LIFE". IT WAS REPORTED THAT THE DEVICES WERE "DEFECTIVE", FAILED TO HOLD SETTING, AND HAD EARLY DEPLETION. A WEEK LATER, IT WAS REPORTED THAT THIS WAS NOT A DEEP BRAIN STIMULATION PROBLEM THAT COULD BE BLAMED ON THE PATIENT'S DOCTORS. THE REPORTER STATED THAT THE DEVICES NEVER WORKED PROPERLY AND CAUSED HIS LEGS TO HURT. IT WAS REPORTED THAT IT WAS AN EQUIPMENT ISSUE. IT WAS NOTED THAT THE DEVICES THE PATIENT HAD EARLIER GAVE HIM THE TREMOR CONTROL HE EXPECTED. IT WAS REPORTED THAT THE PATIENT'S NEW DEVICES DID A "GOOD AND STEADY JOB" OF CONTROLLING HIS ESSENTIAL TREMOR. WITH THE NEW DEVICES, THE PATIENT NO LONGER FELT SLUGGISH, HIS LEGS DID NOT HURT, HIS MOOD IMPROVED, AND HIS GAIT ATAXIA WAS MINIMAL. A WEEK LATER, IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE DEVICES, THE PATIENT EXPERIENCED EXCESSIVE TREMOR AND GAIT ATAXIA. THE PATIENT'S NEUROLOGIST WOULD MAKE ADJUSTMENTS THAT "SEEMED OK" WHILE IN THE OFFICE, BUT A SHORT TIME LATER THE EXCESSIVE TREMOR REAPPEARED AS IF THE PATIENT HAD NO DEEP BRAIN STIMULATION. IT WAS REPORTED THAT A DIFFERENT CLINIC REPROGRAMMED THE DEVICES ON (B)(6) 2012 AND REQUESTED THAT THEY BE CHECKED IN THREE MONTHS. ON (B)(6) 2012, A TEST WAS RUN SHOWING THAT THE LEFT THALAMIC DEVICE WAS SLIGHTLY LOWER AT 3.66 VOLTS AND THE RIGHT THALAMIC DEVICE WAS NORMAL AT 3.71 VOLTS. BETWEEN (B)(6) 2012 THE PATIENT EXPERIENCED "SUDDEN AND PREMATURE FAILURE". A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention