BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3160019 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10046
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8781, LOT# 206380715, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING A CATHETER REPLACEMENT, THE PATIENT STARTED TO SHOW LEG WEAKNESS WHICH SEEMED TO BE CAUSED BY AN OVERDOSE. IT WAS SUGGESTED THAT THE PUMP BE TURNED TO MINIMUM RATE TO MINIMIZE THE AMOUNT OF DRUG INJECTED AND PERFORM A BRIDGE BOLUS WITH A LOWER CONCENTRATION DRUG AT A LATER DATE. THE PHYSICIAN AGREED TO TRY THAT APPROACH. IT WAS NOTED THAT THE PHYSICIAN FELT THAT THE DOSE WAS HIGH. PRIOR TO THE CATHETER REVISION, THE DOSE HAD BEEN INCREASED AS THE PATIENT HAD A LACK OF EFFECT DUE TO A CATHETER MIGRATION. AT THAT TIME, THE DRUG HAD BEEN LEAKING FROM THE DURA. THE PHYSICIANS BELIEVED THAT THE DRUG HAD ACCUMULATED UNDER THE DURA AND LEAKED INTO THE MEDULLARY CAVITY, THUS LEADING TO THE OVERDOSE. AS OF (B)(6), THE DOSING HAD BEEN LOWERED FROM 500MCG TO 100MCG. IT WAS REPORTED THAT, AS OF (B)(6), THE PATIENT HAD RECOVERED AS HE HAD NO PROBLEMS ON THAT SUNDAY OR ON THE DAY OF REPORT. THE DEVICE SYSTEM WAS DELIVERING GABALON. (REFER TO MANUFACTURER REPORT #3007566237-2013-01760, FOR DETAILS PERTAINING TO THE CATHETER MIGRATION AND REPLACEMENT).

    Description of Event or Problem · 1

    PLEASE NOTE THAT THE SERIAL NUMBER FOR THE PUMP INVOLVED IN THIS EVENT WAS ORIGINALLY CAPTURED AS (B)(4) AND ASSOCIATED WITH MANUFACTURER REPORT #3004209178-2013-10046. HOWEVER, SOURCE DOCUMENTS NOTED THE SERIAL NUMBER SHOULD HAVE BEEN (B)(4). THIS HAS BEEN UPDATED IN THE FILE AND NEW INFORMATION WILL BE FILED WITH SERIAL (B)(4) WITHIN MANUFACTURER REPORT #3004209178-2013-10046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260459 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other