BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3052076 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-05990
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, LOT# L74226, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PHYSICIAN NO LONGER TOOK THE PATIENT'S INSURANCE, AND THE PATIENT THOUGHT THE PUMP HAD BEEN EMPTY FOR APPROXIMATELY A WEEK AND A HALF. THE PATIENT WAS IN 'SO MUCH PAIN' THAT HE DESCRIBED AS UNBEARABLE AND HAD BEEN GETTING WORSE. THE PATIENT WENT TO THE HOSPITAL EMERGENCY ROOM ON (B)(6) 2013, WHERE THEY WERE GIVEN ORAL HYDROCODONE AND CYCLOBENZAPRINE FOR MUSCLE SPASMS; HOWEVER, THE PATIENT FELT THAT THE MEDICINE WAS NOT WORKING. THE PATIENT HAD RUN OUT OF THE ORAL HYDROCODONE AND THE PAIN WAS SO BAD HE WAS UNABLE TO GO TO SLEEP ON THE NIGHT OF (B)(6) 2013. THE PATIENT ALSO NOTED THEY BEGAN TO HEAR A BEEPING ALARM ON (B)(6) 2013. THEN ON 03/13/2013, THE PATIENT STATED THE ALARM SOUND CHANGED TO A SIREN SOUNDING ALARM. THE PATIENT'S REFILL DATE WAS SCHEDULED FOR (B)(6) 2013. THE PATIENT WAS EXPERIENCING 'PAIN ALL OVER,' HIS BACK WAS HURTING LIKE A 'STABBING PAIN,' HIS STOMACH WAS 'PULLING, LIKE IT WAS TIGHT,' AND HE HAD A HEADACHE. THE PATIENT DID NOT EXPERIENCE SIGNS OF BEING ITCHY. IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT URINATE. THE PUMP SYSTEM WAS BEING USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AGAIN ON (B)(6) 2013 DUE TO SEVERE PAIN. IT WAS NOTED THAT THE PATIENT HAD BEEN INCARCERATED FOR 6 MONTHS, AND THE PUMP HAD NOT BEEN REFILLED FOR APPROXIMATELY 10 MONTHS, AND THE PATIENT BELIEVED THE PUMP WAS EMPTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154632 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1