BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802481 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08794
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RETURN OF SPASTICITY AND BACLOFEN WITHDRAWAL. IT WAS NOTED THE PATIENT HAD INCREASED SPASTICITY. IT WAS FURTHER NOTED THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) TO MANAGE THEIR SPASTICITY. THE REPORTER STATED THEY WERE UNSURE WHERE THE PROBLEM WAS AND THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) DECIDED TO REPLACE THE PUMP AND CATHETER. IT WAS NOTED THAT THERE WERE NO ISSUES VISUALLY SEEN WITH THE CATHETER. IT WAS FURTHER NOTED THAT HOSPITALIZATION AND SURGICAL INTERVENTION WERE REQUIRED. IT WAS NOTED THAT THE PUMP LOGS WERE CHECKED AND X-RAYS HAD BEEN DONE. IT WAS FURTHER NOTED THAT SIDE PORT ASPIRATION AND PUMP REFILL WERE DONE TO CHECK THE ACTUAL VERSUS EXPECTED VOLUMES. IT WAS NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PUMP CONTAINED GABLOFEN (BACLOFEN). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD VARIABLE ¿EPISODES¿ SINCE IMPLANT. THE REPORTER STATED THE PATIENT WORSENED PROGRESSIVELY THE WEEK BEFORE THE HOSPITALIZATION. IT WAS NOTED THAT MEDICATION WAS ADDED BUT THAT DID NOT WORK. IT WAS FURTHER NOTED THE PATIENT BEGAN ARCHING THEIR HEAD AND TOES TO THE BED AND THEN BACK OF HEAD TO TOES. THE REPORTER STATED THOSE WOULD COME ON EVERY FEW MINUTES WITH SEVERE PAIN. IT WAS NOTED THE PATIENT¿S ¿CPKS¿ WERE UP, THERE WAS NO ITCHING OR FEVER, AND NO SEIZURES AT THIS TIME. IT WAS FURTHER NOTED THE PUMP RESERVOIR WAS ¿A FEW CC¿S OFF.¿ THE REPORTER STATED THE SIDE PORT WAS TOTALLY FINE AND AN ULTRASOUND OF THE PUMP WAS FINE. THE REPORTER FURTHER STATED THAT A CT SHOWED THE CATHETER WAS INTACT WITH ONLY A SMALL AMOUNT OF FLUID OR AIR AT THE POSTERIOR SITE. IT WAS NOTED THAT WHEN THE PATIENT WAS ON A MAXIMUM DOSE OF DILAUDID AND VALIUM ¿ON THE FLOOR¿ THEY WERE STILL HAVING SPASMS. IT WAS FURTHER NOTED THAT IT WAS DECIDED TO SEND THE PATIENT TO THE ICU FOR PAIN AND SPASM CONTROL, PREVENT CPK RISING, AND THEY WERE NO LONGER SAFE ¿ON THE FLOOR.¿ THE REPORTER STATED THE PATIENT DID WELL ON PROPOFOL, BUT WHENEVER THEY TRIED TO EXTUBATE THE PATIENT WOULD GO BACK INTO SPASMS. IT WAS NOTED THE PATIENT¿S PUMP WAS RESTARTED AND THEY WERE GIVEN A SINGLE BOLUS. IT WAS FURTHER NOTED THE PATIENT¿S SPASMS AND SPASTICITY RESOLVED. THE REPORTER STATED THE PATIENT WAS EXTUBATED AND DISCHARGED TWO DAYS AFTER THE PUMP AND CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281596 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization| R