BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112438 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07661
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 24, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4). WHITE COUNT WAS ELEVATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DISTAL (SPINAL) SEGMENT OF THE CATHETER DISLODGED/MIGRATED AND WAS CONFIRMED THROUGH AN MRI/X-RAY OR CT SCAN ON (B)(6) 2013. IT WAS REPORTED THE PATIENT WOULD BE SCHEDULED FOR A PUMP AND CATHETER EXPLANT. THE PATIENT OUTCOME WAS REPORTEDLY ¿NO INJURY¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN. ABOUT ONE AND A HALF WEEK PRIOR TO THE DATE OF THIS REPORT, THE PUMP STARTED ALARMING BECAUSE THE PATIENT HAD MISSED HER REFILL AND THE PUMP WAS EMPTY. THE PATIENT WAS IN THE HOSPITAL ON THE DATE OF THIS REPORT. THE HEALTH CARE PROFESSIONAL (HCP) ASPIRATED THE CATHETER, AND THE CATHETER COULD NOT BE ASPIRATED. THE HCP ALSO DID A DYE STUDY AND THE CATHETER WAS FOUND "OUT OF THE SPACE." THE HCP WANTED TO SHUT THE PUMP OFF. THE PATIENT'S WHITE COUNT WAS ELEVATED AND THE HCP DID NOT WANT TO DO AN EXPLANT ON THE PATIENT. THE PUMP WAS BEING USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211961 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention