BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3233665 · Received July 18, 2013

    Report

    Report Number
    6000030-2013-00188
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2010
    Report Date
    February 2, 2018
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1147-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: CODES NO LONGER APPLY, THE CODE WAS UPDATED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MEDICATIONS IN THE PUMP WERE FENTANYL 2400 MCG, MORPHINE 20 MG AND BUPIVACAINE 6 MG/ML, AND THAT THE PATIENT HAS HAD THIS COMBINATION IN ¿ALL OF 2013¿.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE PATIENT¿S FIRST PUMP THE PATIENT BELIEVED THE HEALTH CARE PROVIDER ¿HAD THE WRONG MEDICATIONS IN THERE. THEY JUST KIND OF PUT THEIR OWN LITTLE MIXTURE OF WHATEVER THEY WANT TO PUT IN THERE. AND THE DOCTOR IN THE CITIES SAID THAT THERE WAS TOO MUCH OF CERTAIN KINDS OF MEDICINE IN THERE. HYDROMORPHONE. HE SAID THE DOSE WAS TOO HIGH, SO MY HUSBAND ENDED UP WITH A GRANULOMA¿. IT WAS REPORTED A DYE STUDY HAD BEEN DONE, HOWEVER, TIMEFRAME OF THE STUDY AND THE RESULTS WERE NOT PROVIDED. A CATHETER REPLACEMENT OCCURRED AS A RESULT OF THE GRANULOMA AT WHICH TIME THE PUMP WAS REPLACED AS WELL (REFER TO MANUFACTURER REPORT # 6000030-2013-00187 REGARDING PLUGGED PUMP AND LEAKING). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE EVENT DATE WAS REPORTED AS (B)(6) 2010. IT WAS REPORTED THE RESULT OF THE DYE STUDY WAS "OKAY." WHEN THE CATHETER WAS REMOVED, IT WAS COMPLETELY CLOGGED. A CHUNK OF THE FIRST CATHETER WAS STILL IN HIS SPINE, HE COULD FEEL IT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER ON 2018-JAN-09 INDICATED THERE WAS A CATHETER FAILURE THAT WAS UNDER INVESTIGATION. THE PATIENT HAD INJURIES OF FAILURE OF THERAPY, PAIN, WITHDRAWAL, HOSPITALIZATION, SURGERY (PREVIOUSLY REPORTED), AND A GRANULOMA (PREVIOUSLY REPORTED). THE DATE OF INJURY WAS NOTED AS UNDER INVESTIGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333359 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R