BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1213296 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06891
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 25, 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 Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN AN AUTO ACCIDENT IN WHICH THE LEFT SIDE OF HIS BODY WAS IMPACTED. AFTERWARD, HE EXPERIENCED A SHOCKING, JOLTING, AND SURGING ON HIS LEFT SIDE WHEN TURNING THE DEEP BRAIN STIMULATOR ON AND OFF. THE LEFT EXTENSION AND BILATERAL DEEP BRAIN STIMULATORS WERE REPLACED IN 2008, (PLEASE REFERENCE MANUFACTURER'S REPORT # 3004209178200805581). THE PATIENT EXPERIENCED INITIAL IMPROVEMENT AND THEN FURTHER EXACERBATION OF SHOCKING SENSATION. WHEN THE NEW NEUROSTIMULATORS WERE TURNED FOUR DAYS LATER, THE PATIENT FELT A SHOCK WITH THE 'BEEPER' AT FIRST. HE THEN FELT SHOCKING WITH THE 'BEEPER' OFF. THE PATIENT'S WALKING WAS POOR WHEN THE DEVICE WAS ON; WHEN IT WAS OFF, THERE WERE NO PROBLEMS. THE PATIENT HAD NO TREMOR. A SKULL X-RAY WAS TAKEN THE FOLLOWING MONTH, (RESULTS NOT REPORTED). THE HCP PLANNED TO REPLACE THE LEFT LEAD THE FOLLOWING MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 79 YR EXTENSION: MODEL 7482| LOT# NFW151158H| LEAD: MODEL 3387| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426