BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1923186 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09105
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A VARIETY OF PROBLEMS WITH HER PUMP DEVICE. THE PT REPORTED ACUTE PAIN AT THE PUMP SITE, WHERE IT WAS STATED THE "TOP OF THE PUMP" FELT FINE, BUT THE BOTTOM OF THE PUMP "FELT LIKE IT WAS JUST BELOW THE SKIN." IT WAS ALSO STATED THE PT FELT LIKE THE PUMP HAD FLIPPED. IT WAS ALSO STATED THE PT HAD "BLACKED OUT FOR HOURS" ON AT LEAST TWO OCCASIONS. IT WAS ALSO STATED THE PT HAD FALLEN MANY TIMES. THE PT WAS STARTED ON MORPHINE, BUT "SHE EXPERIENCED LEG SWELLING, HALLUCINATIONS, AND AUDITORY PROBLEMS." IT WAS STATED THE PT WAS SWITCHED TO DILAUDID AND KETAMINE AND EXPERIENCED "OCCASIONAL LEG SWELLING." IT WAS STATED THE PT SWITCHED TO FENTANYL AND THE SWELLING WENT DOWN, BUT RETURNED. IT WAS STATED THE PT WAS THEN SWITCHED BACK TO DILAUDID AND AN UNIDENTIFIED "NUMBING MEDICATION" BUT EXPERIENCED SWELLING AND WITHDRAWAL. IT WAS STATED THE PT HAD AN INCREASE IN BASELINE PAIN, DIFFICULTY WALKING, AND PARASTHESIA IN HER "PRIVATE PART AREA." IT WAS ALSO STATED THE PT HAD LOST THE USE OF HER RIGHT ARM AND HAND. THE PT ALSO STATED THAT THEIR HEALTH CARE PROVIDER RETRIEVED LESS DRUG THEN ANTICIPATED WHEN THEY REMOVED MEDICATION FROM THE PUMP. THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE MFR REPORT #3004209178-2009-01987 FOR INFORMATION REGARDING THE PT'S PRIOR PROBLEMS WITH PUMP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT # N167970| CATHETER: MODEL 8709SC, LOT # N171986012| EXPLANTED: