BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4953400 · Received July 30, 2015

    Report

    Report Number
    3004209178-2015-14375
    Event Type
    Injury
    Date Received
    July 30, 2015
    Report Date
    July 7, 2015
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N175922028, IMPLANTED: (B)(6)2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6)2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, LOT# N175922028, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8 598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP USED TO MOVE BECAUSE IT WAS SUPERFICIAL AFTER THE PATIENT LOST WEIGHT. THE PUMP WAS DELIVERING BACLOFEN. SPECIFIC PATIENT SYMPTOMS, CAUSE OF THE EVENT, INTERVENTIONS, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT AS PER AN HCP THE PATIENT HAD A PUMP REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015. THE PATIENT WAS SEEN LAST WEEK FOR A PUMP REFILL AND WAS NOTED TO HAVE A 2 INCH BY 2 INCH AREA OF REDNESS WHERE PUMP APPEARED TO BE TIPPING AND PRESSING ON HER SKIN CAUSING IRRITATION. THERE WERE NO SIGNS OF INFECTION; NO FEVER AND NO INCREASE IN WHITE BLOOD CELL (WBC) COUNT OCCURRED. FLUID FROM THE POCKET WAS CULTURED TO MAKE SURE THERE WAS NO INFECTION. THE REDDENED AREA WAS ON THE PROXIMAL / INCISION SIDE OF THE PUMP. THERE WAS NO OPENING OR DRAINAGE. THE SURGEON FELT THE ISSUE WAS DUE TO PRESSURE AND SUPERFICIAL PLACEMENT OF THE PUMP. A POCKET REVISION OCCURRED. THE PUMP WAS MOVED FROM THE LEFT SIDE TO THE RIGHT SIDE OF HER BODY. A NEW POCKET WAS MADE A LITTLE DEEPER AND WAS TACKED DOWN TO THE FASCIA. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS WITHOUT INJURY REGARDING THEIR STATUS AT THE TIME OF THE REPORT. THE PATIENT WAS REPORTED AS HAVING RECEIVED GABLOFEN WITH CONCENTRATION 2000 MCG/ML AT A DOSE RATE OF 925 MCG/DAY; THE DRUG LOT NUMBER WAS NOT AVAILABLE. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS "ALIVE- NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498686 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention