BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4140857 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18294
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 9, 2014
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J10993R44, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR A ROUTINE PUMP REPLACEMENT. THEIR ELECTIVE REPLACEMENT INDICATOR (ERI) WAS IN 3 MONTHS. THEY REPORTED GOOD RESULTS SINCE IMPLANT, AND THERE WAS NO EVIDENCE OF A PROBLEM. THERE WERE NO SYMPTOMS OF INCREASED SPASTICITY OR OF A SPINAL HEADACHE. THEIR DAILY DOSE HAD REMAINED LOW, AND THEY SEEMED TO BE DOING WELL. IMMEDIATELY AFTER OPENING THE PUMP POCKET A LARGE QUANTITY OF CLEAR FLUID WAS EVIDENT. UPON FURTHER INSPECTION, THE EXISTING CATHETER WAS NOTED TO BE SPLIT, AND THE HEALTHCARE PROVIDER NOTED A BREAK IN THE CATHETER. IT APPEARED THAT CEREBROSPINAL FLUID (CSF) WAS BACKING UP AND FILLING THE POCKET. THE CONNECTOR WAS REPLACED ALONG WITH THE PUMP. THE EXISTING CATHETER REMAINED IN PLACE AND WAS PATENT. NO CATHETER SEGMENTS WERE LEFT IN THE PATIENT. THEIR DOSE WAS REDUCED AND THEY WERE ADMITTED FOR OBSERVATION IN THE INTENSIVE CARE UNIT (ICU). THEY WERE TAKING ORAL BACLOFEN AT NIGHT. THEY WERE REPORTEDLY DOING WELL AS OF (B)(6) 2014 AND THEIR HCP NOTED THAT THEY RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP CONTAINED LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620745 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization