BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2882484 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12124
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT LOST PAIN CONTROL IN (B)(6). AN X-RAY WAS PERFORMED AND CONFIRMED THAT THE CATHETER WAS OUT OF THE INTRATHECAL SPACE AND COILED NEAR THE ANCHOR. THE ANCHOR WAS INTACT AND SECURED DOWN TO THE FASCIA, BUT THE ENTIRE SPINAL PORTION OF CATHETER WAS OUT OF THE INTRATHECAL SPACE. THE CATHETER REPLACED. THE DEVICE SYSTEM WAS DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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