BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4014194 · Received August 18, 2014

    Report

    Report Number
    3004209178-2014-15425
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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 PATIENT HAD DRAINAGE FROM THEIR ORIGINAL PUMP. THE PT WAS TAKEN TO THE OR (OPERATING ROOM) AND THE POCKET WAS CLEANED OUT AND THE PUMP WAS REPLACED. THEY STARTED "OOZING" AGAIN AND THEY EXPLANTED EVERYTHING 2 DAYS LATER. ADDITIONAL DETAILS LISTED A STAPH INFECTION. THE PUMP WAS USED TO DELIVER LIORESAL (BACLOFEN). IT WAS FURTHER REPORTED PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT DID NOT HAVE MENINGITIS. THE POCKET WAS CLEANSED AND THE PUMP WAS REPLACED. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492934 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR Required Intervention