BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3113791 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07703
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N328329, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE HEALTH CARE PROVIDER (HCP) REPORTEDLY 'BOTCHED THE JOB' AT IMPLANT. IT WAS REPORTED 'IT' BECAME SEVERELY INFECTED AND IT WAS NOT RECOGNIZED FOR 'ALMOST' THREE WEEKS. IT WAS NOTED IT WAS INCREDIBLY PAINFUL AND THE PATIENT ENDED UP IN THE INTENSIVE CARE UNIT. ANOTHER SURGEON HAD TO REMOVE THE PUMP. IT WAS REPORTED THE PATIENT NOW HAD A BONE INFECTION WITH 'A (B)(6) BUG IN THERE. BASICALLY I HAVE A SPINAL ABSCESS NOW WITH (B)(6).' IT WAS NOTED THE PATIENT AS OF THE WEEK OF (B)(6) 2013 HAD A 'BLOW UP' WITH THEIR HCP AND WAS NO LONGER APART OF THE HCP'S PRACTICE. IT WAS NOTED THE PATIENT WAS 'IN REAL DIRE STRAIGHTS AS FAR AS PAIN MEDS WERE CONCERNED.' THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM PRIOR TO EXPLANT WAS NOT REPORTED. 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
    215858 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R