BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1822578 · Received August 27, 2010

    Report

    Report Number
    3007566237-2010-06552
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCED A REACTION TO A PUMP REFILL. PUMP WAS IMPLANTED IN PT'S STOMACH AND THE ALARM WAS NOT HEARD. THE PUMP HAD 0.1 MM OF MORPHINE AND THE PT WENT FOR A REFILL. WHEN THE PAPER WAS TAKEN OFF THE STOMACH, PT BROKE OUT, GOT EXTREMELY RED, HAD ITCHING AND A BURNING SENSATION THROUGHOUT THE BODY. PT WAS SWEATING PROFUSELY AND PACEMAKER WENT OFF DUE TO PT'S HEART RATE. PT WAS GIVEN EPINEPHRINE, ADAVAN AND PEPCID WHILE AT THE HOSPITAL AND THEN FELL ASLEEP WITHIN 2 MINUTES. AFTERWARDS, PT URINATED FREQUENTLY, WENT INTO WITHDRAWAL, AND COULDN'T EAT OR SLEEP. PT SAID SHE FELT VERY NERVOUS. THE DRUG, CONCENTRATION AND DOSAGE WERE UNK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N143763027