BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032523 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02265
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP SYSTEM WAS IMPLANTED WITHOUT INCIDENCE. THE PUMP HAD BEEN PLACED IN A STERILE GENTAMICIN+SALINE SOLUTION PRIOR TO IMPLANTATION INTO THE PUMP POCKET SITE. THE PUMP WAS USED TO DELIVER MORPHINE (COMMERCIAL, PRESERVATIVE FREE). THE PT REPORTED "VERY GOOD" PAIN RELIEF. TWO WEEKS AFTER IMPLANT, THE SKIN OVER THE PUMP AND CATHETER BECAME RED AND THE PT EXPERIENCED HYPERTHERMIA. A SKIN AND PUMP POCKET SAMPLES WERE TAKEN AND SENT FOR MICROBIOLOGICAL ANALYSIS. BOTH SAMPLES WERE (B)(6). A (B)(6) WAS COLLECTED THROUGH THE CATHETER ACCESS PORT AND MICROBIOLOGICAL TESTING WAS NEGATIVE. IN ORDER TO PREVENT SPREAD OF INFECTION, THE PUMP WAS EXPLANTED. THE PUMP WAS SENT TO THE MICROBIOLOGICAL DEPT AT THE HOSPITAL AND SAMPLES FROM BOTH THE PUMP SURFACE AND THE PUMP RESERVOIR WERE (B)(6). THE PT WAS TREATED WITH ANTIBIOTICS. IT WAS NOTED THAT THE ONLY REFILL THAT HAD OCCURRED WAS THE INITIAL INTRAOPERATIVE REFILL. PER THE REPORTER, THE CENTER DOES NOT USE THE REFILL KIT. THE PT OUTCOME WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention