BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6137664 · Received December 1, 2016

    Report

    Report Number
    3004209178-2016-24940
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    February 1, 2013
    Report Date
    December 1, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    UDI-DI
    00613994779229
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA OPERATIVE NOTES REGARDING A PATIENT RECEIVING BACLOFEN VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS CEREBRAL PALSY AND INTRACTABLE SPASTICITY. IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT WAS ADMITTED AND TAKEN TO SURGERY FOR REMOVAL OF THE PUMP AND CATHETER DUE TO AN INFECTION, AN INFLAMMATORY REACTION TO THE DEVICE, AND SKIN EROSION/EXPOSED PUMP AT THE PUMP SITE. THE PATIENT HAD PRODUCED EROSION OF THE LATERAL ASPECT OF THE PUMP SECONDARY TO REPEATED ABRASION WITH HIS RIGHT UPPER EXTREMITY. DURING THE PROCEDURE, THE PUMP WAS REMOVED AND DISCONNECTED FROM THE CATHETER AND GOOD FLOW WAS DEMONSTRATED. A CSF (CEREBROSPINAL FLUID) SAMPLE WAS SENT FROM THIS CONNECTION. THE CAPSULE OF THE PUMP WAS CULTURED AS WELL. THE CATHETER WAS THEN REMOVED AND A PURSESTRING SUTURE WAS PLACED AROUND THE EXIT SITE OF THE CATHETER. THE ERODED SKIN EDGES IN THE PUMP POCKET WERE TRIMMED; THE WOUNDS WERE IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SALINE SOLUTION; AND CLOSED. STERILE DRESSINGS WERE APPLIED AND THE PATIENT WAS AWAKENED AND RETURNED TO THE RECOVERY SUITE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790281 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20 00613994779229

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R