BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8637444 · Received May 23, 2019

    Report

    Report Number
    3004209178-2019-10174
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    January 1, 2017
    Report Date
    May 23, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL UNKNOWN BACLOFEN 1000 MCG/ML AT 50 MCG/DAY VIA AN IMPLANTED PUMP FOR INTRACTABLE SPASTICITY AND SPINAL CORD INJURY/SPINAL CORD DISEASE. IT WAS REPORTED OVER THE LAST SEVERAL YEARS THE PUMP DOSE HAD BEEN DECREASED DOWN. THE PATIENT¿S TONE HAD "LOOSENED UP" ON ITS OWN. IT WAS REPORTED THE SYMPTOMS HAD IMPROVED AND NOW THE PUMP WAS DOWN TO 50 MCG/DAY. IT WAS NOTED THERE WERE NO PUMP ISSUES AND A DYE STUDY CONFIRMED CATHETER PATENCY. IT WAS ALSO REPORTED THE PATIENT HAD BEEN LOSING WEIGHT AND WAS "SKIN AND BONES.¿ THE PATIENT¿S CURRENT WEIGHT WAS (B)(6) POUNDS. SINCE 2017 THE PATIENT HAS HAD ISSUES WITH NAUSEA, VOMITING, "CAN'T KEEP ANYTHING DOWN", AND PRESSURE SORES. IT WAS NOTED THE PUMP WAS HUGE ON HIS BELLY. THE PATIENT HAD A COMPLETE GASTROINTESTINAL (GI) WORKUP AND NO CAUSE WAS FOUND. IT WAS NOTED THIS WAS AFFECTING THE PATIENT¿S QUALITY OF LIFE, AND CAUSING POSTURE PROBLEMS. THE SURGEON WAS PLANNING TO REMOVE THE PUMP AND THE PUMP WAS TURNED OFF PERMANENTLY ON THE DATE OF THIS REPORT WITH THE CODE. IT WAS CONFIRMED THEY WANTED A PERMANENT SHUT OFF. THE PATIENT AND THE HCP AGREED THIS WAS THE BEST OPTION. THE OPTION OF MINIMUM RATE WAS REVIEWED, BUT AGAIN THEY CONFIRMED THEY WANTED THE PUMP SHUT OFF PERMANENTLY. THE PATIENT¿S GI SYMPTOMS HAD BEGUN IN 2017 (SPECIFIC DATE NOT REPORTED). THE PATIENT DID HAVE ORAL BACLOFEN IF NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429507 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention