BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231125 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06963
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2010
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN OVERDOSE WAS REPORTED, WHEN PATIENT WAS IMPLANTED. IT WAS STATED THAT THE PATIENT HAD AN ALLERGIC REACTION TO MORPHINE. HCP (HEALTH CARE PROFESSIONAL) REPORTED LATER THAT THE CAUSE OF THE EVENT WAS "OVERUSE OF PATIENT ORAL MED". PUMP INFUSE MORPHINE SULPHATE 1MG/DAY 10MG/ML CONC. THE EVENT WAS "A COMBINATION OF ORAL AND INTRATHECAL MEDS. PATIENT WAS SUCCESSFULLY TRIALED WITH 8MG OF MORPHINE SULPHATE (PF) EPIDURALLY ON (B)(6) 2010. ON (B)(6) 2010 PATIENT WAS LETHARGIC AND DIFFICULT TO AROUSE AND WAS BROUGHT TO THE E.R. PATIENT WAS HOSPITALIZED AND HAD DECREASED O2 SATURATION. ORAL MEDS WERE DECREASED AND PUMP MED DOSE WAS DECREASED TO 0.48 MG/DAY AT THE HOSPITAL. CURRENTLY THE PUMP WAS INFUSING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N246806007