BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2904024 · Received January 9, 2013

    Report

    Report Number
    3007566237-2013-00085
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 7482A51, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID: 37642, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 37602, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3387S-40, LOT#: V865889, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: PRODUCT ID 7438, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING AND JOLTING SENSATION. THE REPORTER STATED THAT WHEN THE DEVICE WAS TURNED ON WITH THE PATIENT PROGRAMMER, THE PATIENT FELT A SHOCK. IT WAS NOTED THAT THE REPORTER DID NOT SEE THE NEUROSTIMULATOR BATTERY LIGHT ON THE PATIENT PROGRAMMER. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PARESTHESIA AND DYSKINESIA. THE REPORTER STATED THAT THE PATIENT HAD PARESTHESIA THAT WAS GOING UP THE SPINE AND INTO THE PATIENT'S HEAD, NECK, AND FACE. IT WAS NOTED THAT THIS STARTED A FEW WEEKS BEFORE THE REPORT BUT WAS SEVERE THE DAY OF THE REPORT. THE REPORTER STATED THAT THE PATIENT STARTED HAVING PROBLEMS WITH DYSKINESIA THE DAY OF THE REPORT AND THIS HAD NEVER HAPPENED IN THE PAST. IT WAS NOTED THAT THE PATIENT HAD THREE DEVICES FOR TWO DIFFERENT THERAPIES. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT'S DEVICES HAD BEEN TURNED OFF. IT WAS NOTED THAT THIS DID NOT IMMEDIATELY HELP THE TINGLING AND DYSKINESIA. THE AMOUNT OF MEDICATION THE PATIENT WAS TAKING WAS LOWERED, AND THE SYMPTOMS STARTED TO RESOLVE. THE REPORTER STATED THAT THE PLAN WAS TO TURN ON THE DEVICES ONE AT A TIME OVER THE NEXT FEW DAYS TO SEE IF SYMPTOMS RETURNED. THE PATIENT HAD AN APPOINTMENT WITH HIS HEALTHCARE PROFESSIONAL SCHEDULED FOR (B)(6) 2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DYSKINESIA AND TINGLING RESOLVED WITH THE CHANGES IN THE PATIENT'S MEDICATIONS. THE DBS SYSTEM HAD BEEN REACTIVATED, AND WAS WORKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR THAT SHOCKED THE PATIENT WAS ONLY IMPLANTED IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11937 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR