BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1062922 · Received June 19, 2008

    Report

    Report Number
    6000030-2008-03347
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    July 27, 2007
    Report Date
    May 20, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    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

    RESULTS- OTHER: USED FOR CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED ERYTHEMA AT THE PUMP IMPLANTATION SITE, PAIN OVER ENTIRE BODY AND WAS UNABLE TO EAT HIS MEAL. THE PT PRESENTED TO THE HOSPITAL ON THE SAME DAY, WHERE IT WAS NOTED THAT HIS HAND STRENGTH WAS POOR AND THE PT HAD INCONTINENCE. THE PT WAS AFEBRILE INITIALLY; PENICILLIN AND CEFAMEZINE WERE ADMINISTERED. THE TEMPERATURE WAS RECORDED AT 39.1; VOLTAREN SUPPOSITORY WAS GIVEN. THE PT EXPERIENCED "CONSTRICTION AND TINGLING IN ABDOMEN" AS WELL AS ERYTHEMA AND SWELLING FROM ABDOMEN TO FLANK. THERE WERE NO SIGNS OF MENINGEAL IRRITATION. "DARK AREAS" INDICATIVE OF ABSCESS WERE NOTED ON THE CONTRAST CT. BILATERAL PLEURAL EFFUSIONS WERE ALSO NOTED. THE PT AND HIS FAMILY REQUESTED THAT THE PUMP BE REMOVED DUE TO CONCERN OF RECURRENCE OF ABSCESS IN VICINITY OF THE PUMP. THE PT WAS TAKEN TO SURGERY ON TWO DAYS LATER FOR REMOVAL OF THE PUMP UNDER GENERAL ANESTHESIA. ABSCESSES WERE CONFIRMED IN ABDOMEN AND BACK. THE FLUID FROM BOTH ABSCESSES AND THE CATHETER TIP WERE SENT FOR CULTURE REVEALING STAPHYLOCOCCUS AUREUS. A DRAIN WAS INSERTED. THE PT EXPERIENCED WORSENING BILATERAL UPPER EXTREMITY STIFFNESS A WEEK LATER. THE ANTIBIOTICS WERE CHANGED BASED ON THE SENSITIVITY RESULTS FROM THE CULTURE. ON THE FOLLOWING MONTH, THE BEDREST RESTRICTION WAS REMOVED AND THE PT WAS ABLE TO START STANDING AND WALKING EXERCISES. THE PT HAD "PARTIAL SUTURE REMOVAL; ERYTHEMA WAS NEARLY RESOLVED. THE PT REMAINED HOSPITALIZED FOR AN UNSPECIFIED PERIOD. THE PUMP CONTAINED GABALON. THE HCP REPORTED THAT DURING OUTPATIENT FLUOROSCOPY IN A MONTH PRIOR TO ORIGINAL MONTH, CONTRAST WAS INJECTED INTO THE CATHETER ACCESS PORT OF THE PUMP. INFECTION FROM THE STUDIES AND OTHER PROCEDURES WERE SUSPECTED TO BE THE CAUSE OF THE ABSCESSES IN THE VICINITY OF THE PUMP. ANTIBIOTICS WERE PRESCRIBED PROPHYLACTICALLY AFTER THE PROCEDURE. THE PUMP WAS IMPLANTED OUTSIDE OF THE FASCIA. THE PT IS SUSCEPTIBLE TO INFECTION. THE 2-0 SILK SUTURE WAS USED FOR SECURING THE PUMP AND CATHETER.

    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 69 YR Hospitalization| R CATHETER MODEL 8711 LOT# N077018005| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| MYONAL (50) THREE TIMES DAILY| EXPLANTED: