BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021467 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04245
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SKIN OVER THE IMPLANT SHOWED SIGNS OF POSSIBLE INFECTION WHICH REQUIRED ANTIBIOTIC TREATMENT. THE PUMP REMAINED IMPLANTED AND NO PATIENT SYMPTOMS OR INJURIES WERE REPORTED. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS STILL IMPLANTED AT THE TIME OF REPORT. NO CULTURE HAD BEEN TAKEN AND THE REPORTER DID NOT KNOW WHICH DRUG WAS USED IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124486 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention