BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4240810 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21231
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER INCISION IN BACK BECAME INFECTED, HAD DRAINAGE AND WAS OOZING FLUID. THE PATIENT EXPERIENCED INCISIONAL WOUND OPENING AT THE CATHETER TRACK. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE DATE OF ONSET/ DIAGNOSIS OF INFECTION WAS (B)(6) 2014. THE PATIENT DID NOT HAVE MENINGITIS. THE TYPE OF ORGANISM CULTURED AND CULTURE SOURCE WERE NOT KNOWN. THE PUMP AND CATHETER WERE EXPLANTED AND DISCARDED. THE WOUND WAS HEALING. AT THE TIME OF THE REPORT, THE PATIENT WAS INPATIENT AT THE HOSPITAL AND PATIENT STATUS WAS ALIVE WITH NO INJURY. THE PUMP WAS DELIVERING GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722624 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R