BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1061470 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03203
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT STATED THE EXTENSION LEADS FEEL TIGHT BILATERALLY IN HER NECK. DURING HER SEVENTH PROGRAMMING SESSION WITH THE HCP, THE PT REPORTED INTERIM HISTORY THAT SHE HAD BEEN FALLING ONCE A WEEK. ONE INSTANCE LEFT HER BADLY BRUISED AND WENT TO THE EMERGENCY ROOM FOR ASSESSMENT. SHE BECOMES EASILY FATIGUED AND CANNOT STAND UP FOR LONG PERIODS OF TIME. SHE HAD BEEN DROOLING ON THE RIGHT SIDE OF HER MOUTH. SHE HAD BEEN HAVING NIGHTMARES AND HIT OUT AT OTHERS IN HER SLEEP. FOLLOWING THE REPORTED PROGRAMMING SESSION, THE PT SHOWED IMPROVEMENTS IN SYMPTOMS WITH A NEGATIVE WILSON'S BILATERALLY, FINGER TO THUMB MOVEMENT WAS EASIER TO THE RIGHT, INCREASED ABILITY TO LIFT HER RIGHT FOOT, AND SLIGHT ARM SWING BILATERALLY. THE PT WAS SEEN AT A LATER DATE BY THE NEUROSURGEON. THE PT REPORTED THE NEUROSURGEON SUGGESTED SHE TURN OFF THE GENERATORS TO SEE IF SHE HAD BENEFITED FROM THE PROGRAMMING. AFTER 25 MINUTES, THE PT EXPERIENCED SOME INCREASE IN RIGIDITY, BUT NO TREMOR. IT WAS THEN PROGRAMMED AT THE ORIGINAL SETTINGS WITH INSTRUCTIONS TO TURN OFF AT HOME FOR A LONGER TRIAL. THE NEUROSURGEON REPORTED THE PT EXPERIENCED EMOTIONAL CHANGES ALONG WITH THE PAIN AND TIGHTNESS IN THE NECK AND HEAD. THE PT WAS OFFERED A REVISION OF THE EXTENSIONS. THE PT WAS GIVEN A TEN UNITS TO ASSIST WITH BACK PAIN. THE HCP RECOMMENDED CONTACTING THE MFR TO SEE IF IT WOULD INTERFERE WITH THE GENERATORS. THE PT'S CONCOMITANT MEDICATIONS NOTED WERE: SINEMET, AZILECT, ZOLOFT, TRILEPTAL, NEURONTIN, AND B12 INJECTIONS. THE HCP STATED THE AZILECT MAY BE AGGRAVATING HER SLEEP DISTURBANCE AND INCREASING HER NIGHTMARES WHEN TAKEN AT NIGHT. NO INJURY WAS REPORTED. NO FURTHER OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE. PLEASE SEE MFR. REPORT #3004209178-2008-03202.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R EXPLANTED| LEAD: MODEL 3389 LOT# V022480| EXPLANTED| IMPLANTED| LEAD: MODEL 3389 LOT# V022480| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION: MODEL 7482 LOT# NHU138996V| IMPLANTED| EXTENSION: MODEL 7482 LOT# NHU138995V| EXPLANTED