BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3191483 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10943
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED AN INCREASE IN THEIR PAIN LEVEL AND HAD NOT BEEN FEELING WELL. A CAT SCAN WAS PERFORMED ON (B)(6) 2013 AND REVEALED THAT THE CATHETER WAS BROKEN. THREE WEEKS PRIOR TO THE DAY OF THE REPORT THE PATIENT WAS SEEN BY THE PHYSICIAN. THE HCP CONSIDERED DOING A ¿TEST TO SEE WHERE THE MEDICINE¿S GOING¿ AS THEY DID NOT KNOW WHERE IT WAS GOING. IT WAS INDICATED, THE HCP SAID IT¿S NOT ¿GOING IN THE RIGHT PLACE.¿ THE PATIENT HAD A PUMP FILL THE DAY OF THE REPORT. THERE WAS NO RESISTANCE AND HCP WAS ¿GETTING THE CORRECT AMOUNT OF MEDICATION.¿ THE HCP INDICATED THAT A TEST DID NOT NEED TO BE DONE. THE PATIENT WAS ¿FEELING WORST.¿ THE PUMP WAS DELIVERING DILAUDID AND MARCAINE. IT WAS LATER REPORTED, THE CATHETER WAS BROKEN AND WAS NOT CONNECTED TO THE EPIDURAL PORTION. ¿THE CATHETER COURSES INFERIORLY WITHIN THE CANAL WHERE IT TURNS SUPERIORLY AT LEVEL TWO, THREE LEVEL. AND THE BROKEN END TO THE CATHETER IS WITHIN THE POSTERIOR CANAL, AND L1, 2 SPACE LEVEL, JUST TO THE RIGHT OF THE MIDLINE.¿ THE PATIENT BELIEVED THE MEDICATION WAS NOT GOING IN THE PROPER AREA TO RELIEVE THEIR PAIN. THE PATIENT HAS BEEN UNCOMFORTABLE FOR MONTHS. THE PATIENT WAS SEEKING A PHYSICIAN TO MANAGE THEIR CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290027 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR