BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1062923 · Received June 19, 2008

    Report

    Report Number
    6000030-2008-03313
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 23, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0957-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PT SEEMED TO EXPERIENCE INCREASED LETHARGY AND SOMNOLENCE AND WOULD THEN BECOME OVERLY TIGHT. THE PT ALSO HAD ITCHING. THE PT'S CAREGIVER ASSOCIATED THESE SYMPTOMS WITH THE INTRATHECAL BACLOFEN PUMP AND CATHETER AS 'OVERDOSE' AND 'UNDERDOSE'. THE DEVICE WAS INTERROGATED AND NO ANOMALIES WERE FOUND. THE RESERVOIR VOLUME WAS AS EXPECTED AND THE HEALTH PROFESSIONAL WAS ABLE TO ASPIRATE THROUGH THE CATHETER ACCESS PORT. A ROTOR STUDY WAS ALSO PERFORMED WITH NORMAL RESULTS. THE CARE GIVER DECLINED TO AUTHORIZE AN INDIUM STUDY. THE PT WAS GIVEN ORAL BACLOFEN, WHICH HELPED WITH THE SYMPTOMS, BUT WAS STILL SLEEPY AND HAD BEEN SLEEPING FOR FOUR DAYS EVEN AFTER NOT TAKING ORAL BACLOFEN FOR TWO DAYS. THE PT'S CAREGIVER REQUESTED THE ENTIRE SYSTEM TO BE REPLACED. AT THE TIME OF THIS REPORT, THE PT WAS REPORTED TO BE AT HOME. IT WAS LATER REPORTED THAT THE PT EXPERIENCED CONSTIPATION AND INTERMITTENTLY SPASTICITY AND LEG CRAMPS; THE PRURITUS WAS NOTED IN THE GROIN AREA. THE DIAGNOSIS WAS "R/O ITB WITHDRAWAL". THE PT UNDERWENT AN XRAY WHICH REVEALED THAT THE CATHETER POSITION WAS AT L3 (UNCHANGED). IT WAS ALSO NOTED THAT STOOL FILLED THE COLON WITHOUT BOWEL OBSTRUCTION. A 33.3 MCG BOLUS WAS GIVEN WITH DECREASED TONE FOUR HOURS LATER, BUT PRURITUS INCREASED. ON THREE OCCASIONS, THE HCP SUGGESTED AN INDIUM STUDY, HOWEVER, THE FAMILY REFUSED THE TEST. THE PT PRESENTED TWO WEEKS LATER TO THE ER WITH SIMILAR SYMPTOMS; THE PUMP AND CATHETER WERE REPLACED THE FOLLOWING DAY. THE CATHETER WAS REPLACED DUE TO A TEAR. NO INJURY WAS REPORTED; THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL #: 8709 LOT#: UNK