BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2840455 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10575
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORT EVENT STATUS AND FURTHER EVENT DETAILS. THE PATIENT INDICATED THAT WHEN UNDERGOING A ROUTINE PUMP REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI), THE CATHETER WAS CHECKED INTRA-OPERATIVELY AND CEREBROSPINAL FLUID (CSF) WAS ASPIRATED THROUGH THE SIDE PORT. FOLLOWING THE REPLACEMENT, THE SYMPTOMS STILL PERSISTED WHILE MAINTAINING A STEADY DOSE OF 999MCG/DAY OF GABLOFEN. THE REPORTER STATED THAT THE SPASTICITY HAD RETURNED TO THE LEVEL IT WAS BEFORE THE PUMP WAS IMPLANTED, AND RETURN OF SYMPTOMS HAD BEEN OCCURRING FOR THE 2 MONTHS LEADING UP TO THE REPORT DATE. THE SURGICAL HEALTHCARE PROVIDER (HCP) WHICH THE PATIENT WAS REFERRED TO, AS ALREADY REPORTED, WAS RECOMMENDING AN INDIUM DYE STUDY PRIOR TO A SURGICAL PROCEDURE BEING PLANNED. IT WAS NOTED THAT DURING A RECENT STUDY THE HCP WAS UNABLE TO ASPIRATE, AND DID NOT INJECT. IT WAS NOT CLEAR IF THE REPORTER WAS REFERRING TO AN ADDITIONAL STUDY OR THE STUDY THAT WAS PREVIOUSLY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO PERFORM A CATHETER DYE STUDY BUT WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF) THROUGH THE CATHETER ACCESS PORT (CAP). A CATHETER PROBLEM WAS SUSPECTED. THE HCP SENT THE PATIENT TO A NEUROSURGEON TO HAVE THE CATHETER REVISED. THE NEUROSURGEON REQUESTED THAT DYE BE INJECTED INTO THE RESERVOIR SO THAT HE COULD IDENTIFY THE SOURCE OF THE CATHETER ISSUE. INDIUM WAS INJECTED AND THE PATIENT WAS TO RECEIVE SERIAL SCANS. THE PATIENT'S DOSE WAS DECREASED "IN A COUPLE SERIAL DECREASES" FROM 999MCG/DAY TO A LEVEL OF 500MCG/DAY OF GABLOFEN. THE PATIENT EXPERIENCED LOWER EXTREMITY SPASMS. AT THE TIME OF THE REPORT, THE PATIENT WAS UNDERGOING WORK-UP TO PIN POINT THE SPECIFIC LOCATION OF ISSUE WHICH WAS STILL UNKNOWN. PENDING THE RESULTS OF THE INDIUM STUDY, A REVISION OF THE CATHETER WAS PLANNED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1