BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3910221 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12452
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 13, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8781, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY IN HER LEGS. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) TO RULE OUT WITHDRAWAL SYMPTOMS. X-RAYS WERE DONE. MIGRATION/DISLODGEMENT AT THE CATHETER TIP OCCURRED. AT THE TIME OF THIS REPORT, THE PATIENT WAS TO FOLLOW-UP WITH THE SURGEON FOR A REVISION OR REPLACEMENT OF THE CATHETER. IT WAS NOTED THAT THE PATIENT ALSO HAD A POSSIBLE KIDNEY STONE AND WAS SUFFERING FROM CONSTIPATION. AT THE TIME OF THIS REPORT, THE PATIENT STATUS WAS INDICATED TO BE ¿ALIVE-NO INJURY.¿ THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A SEVERE INCREASE IN SPASTICITY, LOWER EXTREMITY WEAKNESS AND SEVERE STIFFNESS. A CATHETER REPLACEMENT WAS PLANNED, AS THE SURGEON REFUSED TO DO SURGERY UNTIL (B)(6) 2014. WHEN ASKED IF THE PATIENT HAD A KIDNEY STONE, IT WAS NOTED THAT THIS WAS NOT FULLY INVESTIGATED YET, BUT IT WAS NOT RELATED TO THE PUMP THERAPY. THE PREVIOUSLY REPORTED CONSTIPATION WAS LIKELY NOT RELATED TO THE PUMP THERAPY. AN ADDITION OF ORAL BACLOFEN WAS MADE, BUT THE PATIENT COULD NOT TOLERATE THE ORAL BACLOFEN. IT WAS INDICATED THAT THE PATIENT HAD NOT RECOVERED AND THE SYMPTOMS AND/OR ISSUES WERE ONGOING. THIS WAS THE MANAGING HEALTHCARE PROVIDER¿S (HCP) BIGGEST CONCERN SECONDARY TO THE SURGEON¿S DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT¿S CATHETER WAS REPLACED ON 2014-(B)(6). NO FURTHER ACTIONS HAD BEEN TAKEN SINCE THE REPLACEMENT AND, AS OF 2014-08-04, THE PATIENT WAS RECEIVING ADEQUATE THERAPY. NO PRODUCT WOULD BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386528 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention