BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3349286 · Received September 16, 2013

    Report

    Report Number
    3004209178-2013-16252
    Event Type
    Injury
    Date Received
    September 16, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 22, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N121594, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BACK SURGERY 2 WEEKS AGO AND THE SURGEON CUT THE CATHETER DURING SURGERY. A DYE TEST WAS DONE LAST WEEK THAT CONFIRMED THE CUT IN THE CATHETER. THE PATIENT WAS SEEKING A NEW HCP TO DO REPLACEMENT OF THE PUMP AND CATHETER AS THE PATIENT¿S HCP HADN'T RETURNED CALLS AND ONLY REFILLS THE PUMP AND THE IMPLANT HCP WAS NOT AN OPTION FOR REPLACING PUMP DUE TO NOT HAVING PRIVILEGES. THE PATIENT HAD BEEN TO THE EMERGENCY ROOM (ER) TWICE DUE TO PAIN. THE PATIENT WENT INTO THE HOSPITAL SATURDAY AND WAS SENT HOME TUESDAY NIGHT AND NOW THE PATIENT WAS NOT USING THE PUMP AT ALL. PER THE REPORTER THEY TURNED THE PUMP OFF DUE TO THE CATHETER BEING CUT. THE PATIENT ALSO EXPERIENCED WITHDRAWAL SYMPTOMS AND CURRENTLY HAD A FENTANYL PATCH ON AND GETTING OXYCONTIN PILLS. TWO WEEKS AGO THE PATIENT WAS GIVEN DILAUDID AND HYDROCODONE AND NOW THE PATIENT WAS BEING GIVEN DILAUDID. PER THE PATIENT¿S FAMILY THE PUMP WAS DELIVERING MORPHINE AND ONE OTHER MEDICATION BUT SHE COULD NOT RECALL THE NAME OF THE SECOND ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465466 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization