BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2931565 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01046
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PHYSICIAN PROGRAMMER MODEL: 8840, SERIAL# UNKNOWN; CATHETER MODEL: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP MEMORY ERROR MESSAGE OCCURRED WHILE THE PATIENT VISITED THE DOCTOR'S OFFICE DUE TO FEELING "TIGHTER". THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) THE NEXT DAY FOR GENERAL PAIN BUT ONCE ARRIVING AT THE ER THE PATIENT DENIED HAVING PAIN. IT WAS LATER CONFIRMED THAT THE PROGRAMMER THAT WAS USED TO INTERROGATE THE PATIENT DEVICE DID NOT HAVE AN UPDATED SOFTWARE CARD AND COULD NOT RECOGNIZE THE ASCEDA MODEL 8780 CATHETER. ELEVEN DAY AFTER THE FIRST REPORT, THE PATIENT WAS BROUGHT TO THE ER AGAIN REPORTING AN "INCREASED SPASTICITY BURNING IN THE HANDS AND WRIST PAIN". THE PATIENT WAS GIVEN A BOLUS. THE PATIENT WAS BEING INFUSED WITH BACLOFEN VIA THE PUMP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD SOME RESPONSE BUT IT 'WANED; HOWEVER NURSE NOTES COMMUNICATION WITH PATIENT AND FAMILY HAS BEEN A BIT MORE CHALLENGING AS PATIENT AND FAMILY ARE HEARING IMPAIRED AND ALL COMMUNICATION IS BY FAX.' IT WAS REPORTED THE PATIENT HAD CONTINUED TO HAVE FOLLOW-UPS FOR DOSE TITRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36947 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR