BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3033538 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04565
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 5, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK; CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); CATHETER: MODEL 8709SC SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT CATHETER REVISION OCCURRED ON THE DAY OF THE INITIAL REPORT. THE REASON FOR REVISION WAS NOT KNOWN. DURING THE REVISION, A DIFFERENT CATHETER WAS INITIALLY ATTEMPTED, BUT THE CEREBROSPINAL FLUID FLOW WAS "NOT OPTIMAL" SO THAT ONE WAS REMOVED AND THE CURRENT CATHETER WAS PLACED. AFTER THE SURGERY, THE PATIENT WAS SCHEDULED TO HAVE AN MRI "DUE TO OTHER ISSUES UNRELATED TO THE INSERTION OF THE CATHETER." HOWEVER, THE PATIENT "ENDED UP" HAVING MULTIPLE MRIS POST OPERATIVELY DUE TO THE PATIENT COMPLAINING OF AN INABILITY TO MOVER HER LEG. THE MRIS WERE DONE TO TRY AND FIND THE SOURCE/CAUSE OF THE PARALYSIS. IT IS UNCLEAR WHETHER ANY FURTHER ACTION WAS TAKEN OR IF THE SOURCE/CAUSE WAS FULL DETERMINED. PUMP LOGS CONFIRMED MOTOR STALL AFTER MRI, LOGS HAD BEEN READ THREE TIMES IN TWO HOURS AFTER MOTOR STALL OCCURRED WITH NO RECOVERY NOTED. THE DEVICE WAS PROGRAMMED AT MINIMUM RATE DUE TO THE REVISION EARLIER THAT DAY. PATIENT SYMPTOMS WERE HEMI-PARALYSIS AND UNABLE TO MOVE LEG. THE DEVICE SYSTEM WAS USED TO INFUSE BUPIVACAINE AND DILAUDID (HYDROMORPHONE.) NINE DAYS AFTER THE INITIAL REPORT WAS MADE, IT WAS ADDED THAT THE REASON FOR THE CATHETER REVISION WAS "BELIEVED" TO BE BECAUSE, THE CATHETER "SLIPPED OUT OF THE INTRATHECAL SPACE AND THAT IT WAS "BELIEVED" THE PATIENT EXPERIENCED LACK OF EFFICACY. IT WAS ADDED THAT THE MOTOR STALL RECOVERED WITHIN THREE HOURS AND THE PATIENT REMAINED IN THE HOSPITAL FOR "OTHER MEDICAL REASONS." THE DOSE WAS AT THE LOWEST SIMPLE CONTINUOUS AND IT WAS THOUGHT THAT THE PATIENT WAS NOT AT THERAPEUTIC LEVEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137502 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R