BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3102975 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07455
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    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
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED IN MANUFACTURER¿S REPORT #3004209178-2013-07425 THAT [THE PATIENT¿S PUMP POCKET WAS REVISED IN (B)(6) 2013. NO SYMPTOMS WERE REPORTED, AND THE PATIENT OUTCOME WAS NOT KNOWN.] IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS THE PUMP HAD FLIPPED AND THE CATHETER BECAME OCCLUDED OR TWISTED. AT THE PUMP REVISION SURGERY IN (B)(6) 2013, THE ACTUAL RESIDUAL VOLUME OF DRUG IN THE PUMP WAS NOT CHECKED, AND IT WAS ¿JUST ACCEPTED PER TELEMETRY¿. AT THE NEXT REFILL IN (B)(6) 2013, THE PUMP¿S ACTUAL RESIDUAL VOLUME EXCEEDED THE EXPECTED RESIDUAL VOLUME. AFTER INVESTIGATION, IT WAS DETERMINED THAT THE PUMP AND CATHETER WERE FUNCTIONING NORMALLY AT THE TIME OF THE REPORT, AND THE DISCREPANCY DATED BACK TO PRIOR TO THE (B)(6) SURGERY. A CATHETER DYE STUDY AND PUMP ROTOR STUDY WAS PERFORMED ON (B)(6) 2013, AND THE RESULTS WERE NORMAL. THE PATIENT¿S SYMPTOMS INCLUDED SOME INCREASE IN SPASTICITY, BUT NO SERIOUS WITHDRAWAL SYMPTOMS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, AND THEIR OUTCOME WAS NO INJURY. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL.

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY OF ABOUT 20 CC WAS REPORTED. IT WAS FURTHER NOTED THAT 'THEY WERE EXPECTING THREE SOMETHING AND ENDED UP GETTING 20,' INDICATING THE ACTUAL RESIDUAL VOLUME EXCEEDED THE EXPECTED RESIDUAL VOLUME. THE DISCREPANCY WAS NOTICED THE DAY PRIOR TO THE REPORT. THE PATIENT WAS NOTED TO BE DOING WELL, AND IT 'DID NOT LOOK LIKE THE PATIENT WAS WITHDRAWING OR ANYTHING.' THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. IT WAS LATER REPORTED THAT THE VOLUME DISCREPANCY HAD BEEN DETERMINED TO RESULT FROM A PREVIOUS CATHETER OCCLUSION THAT WAS REPLACED SEVERAL MONTHS PRIOR TO THE REPORT. AT THIS REPLACEMENT, THE PUMP WAS NOT REFILLED 'SO THE CORRECT VOLUME WAS NOT RECORDED.' A DYE STUDY AND ROTOR STUDY WERE COMPLETED AND BOTH RESULTS WERE NORMAL. THE PATIENT WAS THERAPEUTIC AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203086 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention