BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2210525 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06212
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 20, 2011
    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
    GA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INITIAL DRUG MORPHINE INFUSED VIA THE PUMP WAS INEFFECTIVE AND WAS CHANGED TO DILAUDID WHICH WAS "SOMEWHAT EFFECTIVE" AND LATER IT WAS CHANGED TO PRIALT. FOLLOWING THIS PT HAD SYMPTOMS OF ITCHING, "SMELLED LIKE EGGS FRYING. TERRIBLE,... ALMOST LIKE I WAS CRAZY". THE MEDICATION WAS CHANGED TO DILAUDID AND LATER BUPIVICAINE WAS ADDED AS WELL. ON (B)(6) 2011, SYMPTOMS OF REDNESS OVER AND AROUND PERIMETER OF PUMP THAT STARTED APPROX 2 MONTHS AGO, UNRELATED TO REFILL WERE REPORTED. IT WAS STATED THAT IT FELT AS IF THE PUMP WAS "PUNCHING OUT OF THE SKIN". ON (B)(6) 2011, INFECTION OVER PUMP PER PHYSICIAN WAS REPORTED. IT COULD HAVE RESULTED FROM NEEDLE STICKS FROM A REFILL BUT SOURCE OF INFECTION WAS UNABLE TO BE DETERMINED. ON (B)(6) 2011, THE PT WAS SUGGESTED PUMP REMOVAL DUE TO INFECTION. HE WAS PLACED ON SULFA DRUGS AND THE STATUS WAS: "IT IS BETTER BUT STILL INFECTED". PT HAD THREE MORE DAYS OF SULFA DRUGS AND REFILL WAS SCHEDULED ON (B)(6) 2011. IT WAS ALSO NOTED THAT THE PHYSICIAN WOULD BE SEEING THE PT PRIOR TO REFILL TO DETERMINE FINAL OUTCOME/RESOLUTION. ON (B)(6) 2011, PT EXPERIENCED PUFFINESS BELOW THE PUMP, WHICH WAS SINCE IMPLANT AND WAS CONCERNED IF THE PUMP WAS LEAKING". A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention CATHETER: MODEL 8709, LOT# N005128719| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N005128719| EXPLANTED: