BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3021111 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04223
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V238014, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION, ALONG WITH A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED, THE PATIENT HAD "AROUND TEN" ADJUSTMENTS TO THE DEVICE, WITH THE LONGEST LASTING ADJUSTMENT BEING "ABOUT" A YEAR. THE LAST ADJUSTMENT WAS (B)(6) 2013. IT WAS SAID DURING THIS VISIT, THE DEVICE WAS ADJUSTED THREE TIMES. THE FIRST TWO ADJUSTMENTS LASTED "10 OR 15" MINUTES, FOLLOWED BY A "LOSS OF THAT GOOD FEELING." THE THIRD ADJUSTMENT RESULTED IN A JOLTING OF HIS ARM "A BIT." IT WAS REPORTED, THE PATIENT WAS NOT FEELING WELL FOR THE PAST FOUR TO FIVE WEEKS, PRIOR TO THIS REPORT DATE, AND HIS SYMPTOMS CAME BACK "A BIT." IT WAS STATED, THE PATIENT FELT "FAIRLY WELL" FOR "A WEEK," AND THEN THE WEEK PRIOR TO THIS REPORT DATE, THE PATIENT STARTED GETTING NUMBNESS IN HIS JAW. THE STIMULATION WAS TURNED OFF, BUT THE PATIENT "WASN'T SURE" IF THAT HELPED. WHEN THE DEVICE WAS TURNED BACK ON, A "TERRIFIC SHOCK" WAS FELT. THE PATIENT DESCRIBED THIS THAT HIS FEET CAME UP IN THE AIR AND HE LOOKED LIKE HE HAD BEEN DEFIBRILLATED. THE PATIENT WAS SCHEDULED TO SEE HIS PHYSICIAN ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT THE PATIENT WAS SUPPOSED TO GET TINGLING SENSATION WHEN THE DEVICE WAS TURNED ON BUT HE WAS GETTING A SHOCK AS REPORTED PREVIOUSLY. THE PATIENT WAS TOLD THAT HE WOULD GET STINGING SENSATION IN HIS JAW DURING ADJUSTMENT. THE STINGING SENSATION IN PATIENT¿S JAW DID NOT GO AWAY AND IT GOT WORSE AFTER ADJUSTMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAD NOT BEEN STUTTERING BUT SINCE HE HAD THE LAST ADJUSTMENT, ¿IT¿S GOTTEN WORSE.¿

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC. THE PATIENT HAD NOT TURNED THE DEVICE ON OR OFF SINCE THE LAST REPROGRAMMING SESSION. THE PATIENT INSISTED THE STIMULATION WAS STRONGER THAN BEFORE, HOWEVER, THE HEALTH CARE PROFESSIONAL NOTED THE SYSTEM WAS FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124459 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1