BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021439 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04242
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCESSORY: MODEL 8578 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), CATHETER: MODEL 8709 SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), CATHETER: MODEL 8709 LOT# J10842R46, IMPLANTED: 2001 (B)(6), ACCESSORY: MODEL 8578 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6). (B)(4). "DISCONNECTED <(>&<)> RECONNECTED THE SUTURELESS CONNECTOR" "DIDN'T LIKE THE WAY IT LOOKED WHEN RECONNECTED" ASKED FOR A REPLACEMENT".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. DATE OF ONSET OF INFECTION WAS (B)(6) 2013. THE LAST REFILL WAS (B)(6) 2013. SIGNS AND SYMPTOMS OF INFECTION WERE INDICATED AS SWELLING AND REDNESS AT THE DEVICE POCKET. A BLOOD CULTURE WAS OBTAINED FROM THE DEVICE POCKET, AND NO GROWTH WAS INDICATED. THE PATIENT RECEIVED IV ANTIBIOTICS. THEY WERE CONTINUING TO OBSERVE THE PATIENT BUT AT THE TIME OF THIS REPORT THERE HAD BEEN NO DRUG WITHDRAWAL. IT WAS ALSO STATED LATER THAT THE PHYSICIAN DID NOT LIKE THE WAY IT (SUTURELESS CONNECTOR) FIT WHEN IT WAS RECONNECTED AFTER THE PUMP POCKET WASH; THE FITTING WAS "JUST NOT TIGHT'. THE SUTURELESS CONNECTOR WAS REPLACED "TO BE SURE" AND BECAUSE THE PHYSICIAN DID NOT WANT TO CLOSE THE PATIENT UP WITH THE OLD CONNECTOR STILL ATTACHED.

    Description of Event or Problem · 1

    A "POSSIBLE INFECTION" AT PUMP POCKET WAS REPORTED, A "POCKET WASH" WAS DONE "IN AN ATTEMPT TO SALVAGE THE SYSTEM." CULTURE TAKEN FROM DEVICE POCKET, NO RESULTS REPORTED. DURING THE POCKET WASH THE DOCTOR DISCONNECTED AND RECONNECTED THE SUTURELESS CONNECTOR AND "DIDN'T LIKE THE WAY IT LOOKED" AFTER RECONNECTION AND ASKED FOR A REPLACEMENT, THE DEVICE NOT TO BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. THE SYMPTOMS WERE REDNESS AT THE PUMP POCKET. THE DOCTOR ALSO VOICED CONCERN DURING THE PROCEDURE THAT THE REFILL PORT WAS ORIGINALLY PLACED "DIRECTLY BELOW" THE INCISION, "FORCING" HIM TO DO THE SAME AT THE REPLACEMENT WHICH OCCURRED IN (B)(6) 2012. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE DEVICE SYSTEM WAS USED TO INFUSE LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124439 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Required Intervention