BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3202899 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00079
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC
    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 8709, LOT# J10932R56, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A RESERVOIR REFILL APPOINTMENT WHICH LED TO WITHDRAWAL SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302268 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other