BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3981579 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13981
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 15, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE DEVICE POCKET DIAGNOSED ON THE DAY OF REPORT. A CULTURE WAS TAKEN BUT THE TYPE OF ORGANISM WAS NOT SPECIFIED. THE DEVICE SYSTEM WAS EXPLANTED ON (B)(6) 2014. ANTIBIOTIC TREATMENT WAS REPORTEDLY NECESSARY. IT WAS NOTED THAT THERE WAS NOTHING WRONG WITH THE PRODUCT, AND THAT THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. THE PATIENT'S PUMP WAS INTENDED TO INFUSE DILAUDID AND BACLOFEN. IT WAS LATER REPORTED THAT PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED, HOWEVER IT WAS NOT KNOWN WHICH ONES. THE PATIENT HAD NO SYMPTOMS OF MENINGITIS, BUT THE MANUFACTURER'S REPRESENTATIVE WAS NOT POSITIVE THAT THE PATIENT DID NOT HAVE MENINGITIS. THE LAST REFILL WAS IN (B)(6) 2014. THE PATIENT REPORTEDLY HAD NO SIGNS OR SYMPTOMS AT ALL OF AN INFECTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456842 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention