BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193095 · Received July 21, 2011

    Report

    Report Number
    3004209178-2011-05654
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT DID NOT HAVE ANY SYMPTOMS AND APPEARED TO BE DOING WELL AND SPASTICITY RESPONDING TO A STARTING DOSE OF 100 MCG/ML OF BACLOFEN FOLLOWING A REFILL WHICH INVOLVED REMOVING THE IMPLANT SALINE AND FILLING PUMP WITH 37-38 CC OF 500 MCG/ML OF BACLOFEN AND SIMPLE CONTINUOUS INFUSION OF 100MCG AROUND 10AM ON (B)(6) 2011 (1 DAY FOLLOWING PUMP IMPLANT). IT WAS LATER REPORTED THAT THE HEALTH CARE PROVIDER HAD SOME DIFFICULTY WITH PROGRAMMING BOLUS TO PRIME THE PUMP TUBING AND CATHETER WITH BACLOFEN AND THAT HE REMOVED ONLY 1 CC OF SALINE FROM THE PUMP PRIOR TO FILLING WITH BACLOFEN AND CLOSER TO 10CC OF SALINE WAS EXPECTED. THERE WAS NO EVIDENCE OF A POCKET FILL AND INJECTABLE FLUIDS WERE THE PROPER COLOR. SAID HE INJECTED 3 CC OF 500 MCG/ML OF BACLOFEN (TO RINSE NEW PUMP AND BRING CONCENTRATION UP TO 98%) AND WAS ABLE TO WITHDRAW THE 3 CC BACK. THE 3 CC OF BACLOFEN WAS DISCARDED AND THEN PROCEEDED TO FILL PUMP WITH REMAINING 37-38CC OF 500 MCG/ML OF BACLOFEN AND PROGRAMMED A BOLUS TO FILL PUMP TUBING AND CATHETER OVER A 25 MIN PERIOD. THE PT WAS DOING FINE AND WAS STARTING TO HAVE SOME NICE RELIEF OF HER SPASTICITY LATER THAT DAY. THE PT DID NOT HAVE ANY SYMPTOMS RELATED TO THE EVENT. THE DRUGS USED IN THE PUMP AT THE TIME OF THE EVENT WERE SALINE AT IMPLANT AND LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: