BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1212183 · Received October 22, 2008

    Report

    Report Number
    2182207-2008-06776
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    May 2, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT TOOK AN OVERDOSE OF TYLENOL. THE PT HAD CONTACTED EMS AND HAD NOTIFIED THIER PHYSICIAN. THE PT WAS HOSPITALIZED FOR MEDICAL CLEARANCE, AND THEN PSYCHIATRIC CARE. WHILE IN THE EMERGENCY DEPT, THE PT HAD REPORTED TO STAFF HE HAD TAKEN THE TYLENOL 36 HOURS PRIOR, AND WAS CONCERNED ABOUT LIVER DAMAGE. THE PT WAS SEEN BY A PHYSICIAN FOR DBS ADJUSTMENTS WHILE IN THE HOSP. NO OTHER TREATMENTS WERE REPORTED. THE PT SHOWED MARKED IMPROVEMENT IN HIS DEPRESSION, AND WAS DISCHARGED NINE DAYS LATER. THE PT REMAINS IN REMISSION. THE PT'S DEVICE WAS REPLACED ABOUT TWO AND HALF MONTHS LATER DUE TO ROUTINE, EXPECTED, REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R LEAD MODEL 3387IES, LOT# UNK, IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7482, LOT# UNK, IMPLANTED: