BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4241982 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21273
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED SEVERAL MONTHS OF URINARY ISSUES AFTER ¿THIS LAST PUMP REPLACEMENT SURGERY¿ (SEE MANUFACTURERS REPORT NUMBER 3004209178-2013-16796). THE PATIENT¿S BLADDER WAS ¿SHUTTING DOWN¿; THEY HAD TO BE CATHETERIZED; AND THEY SUFFERED THROUGH SEVERAL UT (URINARY TRACT) INFECTIONS, ONE OF WHICH PUT THEM IN THE HOSPITAL ON IV (INTRAVENOUS) ANTIBIOTICS. THE DRUG THE PUMP WAS BEING USED TO INFUSE WAS UNKNOWN. ALTHOUGH INTERVENTIONS WERE NOTED, THE OUTCOME WAS IMPLIED TO HAVE RESOLVED. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721724 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention