BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3040435 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04842
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 11, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING. THE CATHETER WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE REPLACED. THE PUMP WAS NOTED TO STILL HAVE HAD '75 MONTHS ERI LEFT,' AND IT WAS SUSPECTED THAT THE PUMP WAS REPLACED IN ERROR. IT WAS UNKNOWN WHY THE CATHETER WAS REPLACED, THOUGH IT WAS REPORTED AS A 'NORMAL CATHETER REPLACEMENT.' IT WAS LATER REPORTED THAT THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE. IT WAS UNKNOWN WHAT EXACT SYMPTOMS THE PATIENT WAS HAVING, BUT THE MANAGING PAIN PHYSICIAN SCHEDULED HIM FOR A CATHETER REPLACEMENT BASED ON THEIR SYMPTOMS AND EXAMINATION. THE DISTAL SEGMENT OF THE CATHETER HAD BACKED OUT OF THE INTRATHECAL SPACE AND WAS 'WADDED UP' IN THE BACK UNDER THE ORIGINAL SPINE INCISION. THE PATIENT WAS THOUGHT TO HAVE NOT ENCOUNTERED ANY ADDITIONAL PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142767 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention