BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3841247 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09920
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8575, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED REITERATED AN EVENT THAT HAPPENED 4 YEARS PRIOR. IT WAS STATED THAT THE HCP ALMOST LET THE PATIENT DIE. THE REPORTER HAD NO ADDITIONAL INFORMATION AND DID NOT WANT TO "RE-HASH" THAT HAPPENED. IT WAS NOTED THAT THE PATIENT WAS RELOCATING FROM OHIO TO ILLINOIS AND REQUESTED PHYSICIAN LISTINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH THE PATIENT¿S SECOND PUMP METHICILLIN-RESISTANT ((B)(6)) STARTED TO EAT THROUGH THE SKIN. IT WAS NOTED THE (B)(6) WAS PRESENT BEFORE IMPLANTATION OF THE SECOND PUMP AND DID NOT AFFECT THE FIRST PUMP. THE SECOND PUMP WAS IN FOR ABOUT 4 MONTHS AND IT STARTED TO GET SORE AND TENDER. THE PATIENT WAS ON 31 MILLIGRAMS OF DRUG IN A 24 HOURS PERIOD AND WAS BEING FILLED EVERY 5 WEEKS. IT WAS NOTED THEY KEPT INCREASING THE PUMP. FOR 18 MONTHS, THE PAIN WAS BLAMED ON A HERNIA INCISION AND THE PATIENT WAS TOLD THAT HE GOT THE HERNIA FROM A 3RD BACK SURGERY. IT WAS ALSO NOTED THE PATIENT GOT MRSA FROM THE HERNIA SURGERY. ON (B)(6) 2011, THE PUMP BROKE THROUGH THE SKIN AND THE PATIENT WENT TO THE EMERGENCY ROOM. THE CLINICIAN PROGRAMMER READ THE BATTERY AND VERIFIED IT WAS ¿31.009 2 DAY.¿ IT WAS DETERMINED THE CATHETER WAS BROKEN AND 2 DAYS LATER THE INFECTED PUMP WAS REMOVED AND ALSO THE CATHETER WAS REPLACED. THE MEDICATION DELIVERED BY THE PUMP HAD ALWAYS BEEN DILAUDID. IT WAS LATER REPORTED THE SYSTEM WAS REPLACED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319632 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Life Threatening| R