BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3981491 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13978
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AROUND THEIR DEVICE FOLLOWING SURGERY. THE AREA HAD TO BE DRAINED AND WAS THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PUMP WAS USED TO INFUSE AN UNKNOWN DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456489 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention