BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3935241 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13014
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, LOT# N152404, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS REMOVED DUE TO AN INFECTION AT THE PUMP SITE. THERE WAS NO MALFUNCTION OF THE PUMP OR CATHETER. THE INCISION SITE LEAKED CLEAR FLUID A LOT AND THE PATIENT HAD HEADACHES. THE PATIENT WAS CONSTANTLY GOING TO THE DOCTOR, WHO TOLD HER TO USE ¿SPANX¿ TO HOLD THE PUMP IN PLACE. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT ENDED UP GOING TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED AFTER HER PRIMARY CARE PROVIDER (PCP) TOLD HER THE INFECTION WAS TURNING INTO ¿MENGA¿. THE PATIENT HAD RED LINES GOING UP HER SPINE. HER FACE AND ARMS WERE BROKEN OUT AND IT LOOKED LIKE MEASLES. THE PHYSICIAN ASSISTANT (PA) SAW THE WOUND LEAK, BUT DID NOT DO ANYTHING AT THE TIME. FORTY EIGHT HOURS AFTER THE PUMP WAS REMOVED, THE PATIENT EXPERIENCED SEVERE WITHDRAWALS. AT THIS TIME, THE PATIENT WAS HOSPITALIZED FOR WITHDRAWALS AT A 5-DAY REHABILITATION FACILITY. THE PATIENT WAS RELEASED AND THEN HOSPITALIZED AGAIN THE FOLLOWING DAY FOR WITHDRAWALS. THE PATIENT WAS ADMITTED A THIRD TIME FOR WITHDRAWAL AND THEN WENT TO ANOTHER REHABILITATION FACILITY. THE PATIENT WAS IN AND OUT OF THE HOSPITAL FOR A TOTAL TIME OF 5 WEEKS POST-EXPLANT. THE REPORTER INQUIRED IF THE PATIENT WAS SUPPOSED TO BE GIVEN INTRAVENOUS (IV) MEDICATION TO HELP CONTROL HER WITHDRAWAL SO HER BODY WOULD NOT HAVE BEEN PUT IN SUCH SHOCK. AT THE TIME OF THE PUMP EXPLANT, THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, BUPIVACAINE AND HYDROMORPHONE. AT THE TIME OF THIS REPORT, THE PATIENT¿S HEALTHCARE PROVIDER (HCP) WANTED TO PUT THE PUMP BACK IN AND THE PATIENT WAS CONCERNED ABOUT INFECTION AND WITHDRAWAL AGAIN. THE PATIENT¿S WITHDRAWAL EXPERIENCED CAUSED HER A LOT OF ANXIETY. THE PATIENT DID NOT WANT TO REPEAT HER EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413495 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R