BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3180076 · Received June 20, 2013

    Report

    Report Number
    3007566237-2013-02037
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8780, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS IN THE CLINIC ON 2013-(B)(6) AND ¿WAS DOING FINE¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ONE WEEK FOLLOWING DEVICE IMPLANT WITH HEADACHE. THE WOUNDS APPEARED NORMAL PER THE HEALTHCARE PROVIDER (HCP) AND THE PATIENT WAS TOLD THEY MAY HAVE HAD A SPINAL HEADACHE. ON (B)(6) 2013 THE PATIENT WAS DIAGNOSED WITH MENINGITIS AND WAS ADMITTED TO THE HOSPITAL. THE PUMP AND CATHETER WERE EXPLANTED ON (B)(6) 2013. THE PATIENT REMAINED HOSPITALIZED FOLLOWING EXPLANT FOR TREATMENT OF MENINGITIS. THE REPORTER ASSUMED THERE WERE OTHER PATIENT SYMPTOMS AS THE PATIENT WOULD NOT HAVE BEEN TESTED FOR MENINGITIS OTHERWISE; HOWEVER, THE SYMPTOMS WERE UNKNOWN. IT WAS ALSO NOTED THAT MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, WAS NOT SPECIFIED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE DEVICE SYSTEM WAS USED FOR PAIN AND DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280558 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R