BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3756525 · Received April 17, 2014

    Report

    Report Number
    3004209178-2014-07413
    Event Type
    Injury
    Date Received
    April 17, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N232032, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS. A FEW DAYS PRIOR TO THIS REPORT, THE PATIENT WAS IN REALLY BAD PAIN, SO A TEST WAS PERFORMED, WHICH INDICATED THAT THE CATHETER WAS DISLODGED. ON THE DAY PRIOR TO THIS REPORT, THE PATIENT HAD A PUMP REPLACEMENT AND A NEW CATHETER IMPLANTED. THERE WAS NO PROBLEM INDICATED WITH THE PUMP. IT WAS REPLACED BECAUSE IT WAS 5 YEARS OLD. THE REPORTER LISTED FENTANYL, BACLOFEN, DILAUDID AND MORPHINE AS PUMP MEDICATIONS. HOWEVER, THE REPORTER WAS NOT CERTAIN IF THOSE DRUGS WERE IN FACT IN THE PUMP. THE ONLY THING THE REPORTER WAS CERTAIN OF WAS THAT THERE WERE 4 DIFFERENT DRUGS. IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER (HCP) DID A DYE STUDY ON (B)(6) 2014 AND FOUND THAT THE CATHETER WAS IN THE WRONG LOCATION. THE PATIENT WAS DUE FOR A PUMP REPLACEMENT NEXT YEAR, SO BOTH THE PUMP AND CATHETER WERE REPLACED. AT THE TIME OF THIS REPORT, THE HCP WAS CHANGING THE DOSE FOR THE PATIENT. THE PATIENT WAS FEELING MUCH BETTER. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, CLONIDINE, BUPIVACAINE AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234002 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention