BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232863 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11942
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS USED TO INFUSE MORPHINE; THE REPORTER WAS UNABLE TO PROVIDE SPECIFIC SYMPTOMS THAT THE PATIENT HAD EXPERIENCED AT THE TIME OF THE INFECTION. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2013 AND WAS RECEIVING ¿GOOD THERAPY¿ WITH THE NEW DEVICE. THEY HAD NO FURTHER INFORMATION TO PROVIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP AND CATHETER WERE REMOVED IN (B)(6) 2013 DUE TO INFECTION. IT WAS STATED THAT IN (B)(6), PATIENT HAD A HERNIA REPAIR AND SHORTLY AFTERWARDS THE MESH BECAME INFECTED. THE INFECTION SPREAD TO THE PUMP POCKET AND THE SYSTEM WAS REMOVED. SHE WAS ON IV ANTIBIOTICS FOR SEVERAL MONTHS. THE INFECTION RESOLVED AND A NEW CATHETER AND PUMP WERE IMPLANTED AS OF THE DATE OF THIS REPORT. DRUG DELIVERED VIA THE DEVICE WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333387 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention