BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3040562 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04847
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, LOT# N180031008, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THE PUMP INCREASED AND WAS IMPROVING IN PAIN CONTROL. IT WAS DETERMINED THE PATIENT HAD A LONG STANDING HISTORY OF PROSTATE PROBLEMS AND HAS HAD TO IN/OUT CATH HIMSELF IN THE PAST FOR URINARY RETENTION. HE CONTINUED TO BE FOLLOWED BY INFECTIOUS DISEASE HCP'S, AND HAD A LARGE SEROMA. THEY HAVE CONTINUED TO DRAIN THIS AND THE PUMP MANAGEMENT HCP CALLED THE INFECTIOUS DISEASE HCP'S ON (B)(6) 2013 WITH A REQUEST TO STOP DRAINING THE SEROMA, FOR FEAR THEY WOULD INTRODUCE BACTERIA INTO THE POCKET

    Description of Event or Problem · 1

    FURTHER, THE PATIENT WAS TREATED BY INFECTIOUS DISEASE CLOSE TO THE POST OP PERIOD FOR AN INFECTED POCKET. THE PATIENT WAS TREATED BY A PHYSICIAN VIA PIC LINE WITH ANTIBIOTICS FOR EIGHT WEEKS AND THERE WAS TALK OF REMOVING THE PUMP. HOWEVER, THE INFECTION DID RESOLVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY RETENTION, IN DWELLING CATHETER, AND CELLULITIS "APPEARANCE" OVER PUMP POCKET. IT WAS REPORTED THAT THE PATIENT WAS TAKING TO THE ER AND "3 LITERS" WERE DRAINED FROM THE BLADDER AND THE PATIENT WAS STARTED ON FLOWMAX. THE PUMP RATE WAS ALSO DECREASED. THE PATIENT HAD A 2ND ER VISIT WITH "ANOTHER 3 LITERS" DRAINED. "REDNESS" AND "CELLULITIS APPEARANCE" WERE FOUND OVER THE PUMP SITE. IT WAS UNKNOWN IF ANTIBIOTICS WERE STARTED OR WHAT THE RESULTS OF THE CULTURE WERE. AN "IN DWELLING CATHETER" WAS REPORTED, IT WAS UNCLEAR IF THAT WAS ASSOCIATED WITH THE URINARY RETENTION. THE PUMP WAS INFUSING INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143114 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other| R