BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231118 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06933
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    November 1, 2008
    Report Date
    August 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 AN UNDERDOSE WAS INITIALLY REPORTED WITH SYMPTOMS OF ALTERED MENTAL STATUS, EXAGGERATED REBOUND SPASTICITY AND MUSCLE RIGIDITY. HCP (HEALTH CARE PROFESSIONAL) STATED THAT ONE SIDE OF THE PT WAS RIGID, BUT THE OTHER SIDE THAT WAS AFFECTED BY HER PREVIOUS STROKE HER LIMBS WERE NOW CONTRACTED & ROTATING INWARD. IT WAS ALSO NOTED THAT THE PT HAD BEEN ON A HIGHER DOSE OF BACLOFEN EVER SINCE THE PUMP WAS REPLACED. PT ALSO HAD FEVER. IN ADDITION PT HAD INCREASED TONE OVER THE LAST COUPLE WEEKS AND IN THE LAST TWO DAYS HAD BECOME WORSE. HCP STATED THAT PT LOOKED AT HER LIKE "A DEER IN HEADLIGHTS" AND DID NOT COMPREHEND WHAT IS SAID. THERE WERE NO ALARMS AND PT WAS AT HOME. PT WAS LATER TAKEN TO THE EMERGENCY ROOM. IT WAS STATED THAT THE PT MAY BE HAVING ANOTHER STROKE AND IT WAS FELT THAT THERE WAS NO ISSUE WITH THE PUMP, BUT MAY BE THE DRUG. THE DRUG INFUSED VIA THE PUMP WAS COMPOUNDED BACLOFEN. THE PT WAS DROWSY, INDICATING OVERDOSE. ANY PUMP ALARMS, VOLUME DISCREPANCIES OR TESTS WERE REPORTED AS UNK. ON (B)(6) 2011, IT WAS REPORTED THAT SINCE THE SECOND PUMP REPLACEMENT IN (B)(6) 2008, PT'S RIGIDITY HAD RETURNED, PT WOULD GET SHAKING AND TREMORS OF HER ARM AND LEG. A (B)(4) STUDY, X-RAY DID NOT REVEAL ANY PUMP ISSUE. PT HAD BEEN TAKING EFFEXOR XR FOR THE PAST 14 YEARS, MOST RECENTLY WHEN SHE MISSED EFFEXOR DOSES FOR 3 DAYS, HER RIGIDITY SEEM TO BE UNDER CONTROL. ON (B)(6) 2011 A CONFIRMED MOTOR STALL WAS REPORTED WITH NO RECOVERY RECORDED. ON (B)(6) 2011 A (B)(4) STUDY WAS DONE AND THE SYSTEM WAS CONFIRMED AS PATENT. ON (B)(6) 2011 A MOTOR STAFF OCCURRED AT 0553 WITH A RECOVERY AT 0614. LATER A RESET OCCURRED AT 0732 WITH A LOW BATTERY AND PUMP WENT IN TO SAFE STATE ALL ON (B)(6) 2011. ON (B)(6) 2011, TELEMETRY CONFIRMED A CRITICAL ALARM - PUMP IN SAFE STATE, RESET OCCURRED EVENT LOGS CONFIRM LOW BATTERY RESET, AND SAFE STATE MESSAGES OCCURRED ON (B)(6) 2011. PT WAS TAKING ORAL BACLOFEN AND WAS REPORTED AS "DOING BETTER". PRIOR TO THE RESET THE PT WAS AT 200MCG/DAY. IT WAS LATER REPORTED THAT PT BECAME STIFF AS PUMP WENT INTO SAFE STATE, WENT INTO WITHDRAWAL. PHYSICIAN DETERMINED THAT THE PUMP WAS 2.5 YEARS OLD, ALARMING AND NOT WORKING AND REPLACED IT. PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N177541031| IMPLANTED:| EXPLANTED: