BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3983622 · Received August 6, 2014

    Report

    Report Number
    6000030-2014-00104
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 14, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, LOT # L69913, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER PUMP REMOVED IN 2002 BECAUSE WASN¿T USING IT BUT THE HEALTH CARE PROVIDER (HCP) LEFT THE CATHETER. THEN, IN 2010, THE HCP REMOVED THE CATHETER BECAUSE IT WAS ¿CAUSING PROBLEM.¿ PART OF THE CATHETER HOWEVER WAS LEFT BECAUSE IT WAS FUSED IN THE AREA. IT WAS ALSO REPORTED THE PATIENT HAD A LOT OF PAIN IN THE THORACIC AREA WHERE THE CATHETER IS LOCATED SINCE ¿ABOUT 2 MONTHS AGO.¿ THE PAIN GRADUALLY STARTED BUT IT WAS NOTED THE PATIENT ALWAYS HAD PAIN IN THE AREA, JUST MORE NOW. IT WAS NOTED THE PATIENT HAD A DISLOCATED RIB HEAD AND A FRACTURE ¿IN THE AREA¿ AND THAT SHE HAS RSD (REFLEX SYMPATHETIC DYSTROPHY). THEREFORE, THE PATIENT WASN¿T SURE IF THE CATHETER WAS THE CAUSE OF THE NEW PAIN EITHER. PREVIOUS MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM CONSISTED OF BUPIVACAINE, DILAUDID AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461114 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention