BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2120028 · Received June 8, 2011

    Report

    Report Number
    3007566237-2011-04186
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, CLINICAL INFO ABOUT POCKET FILLS SYNCHROMED II AND SYNCHROMED EL IMPLANTABLE DRUG PUMPS, PHYSICIAN COMMUNICATION ((B)(6) 2011).

    Description of Event or Problem · 1

    DURING A USABILITY STUDY ON (B)(6) 2011, A POCKET FILL OCCURRED. THE PT REPORTED FEELING SLEEPY WITHIN ABOUT 5 MINUTES AFTER A PUMP REFILL WAS COMPLETED. THE PHYSICIAN ASPIRATED 15CC OUT OF AN EXPECTED 20CC OF NEW INJECTED MIXTURE. IT WAS SUSPECTED THAT THE NEEDLE "POPPED" OUT OF THE PORT DUE TO THE PRESSURE IN THE RESERVOIR. AFTER ASPIRATING THE 15CC, THE NEEDLE WAS PULLED OUT OF THE PORT AND THE NEEDLE TIP WAS PUSHED AGAINST THE FACE OF THE PUMP (SO THAT THE NEEDLE WAS INSIDE THE PUMP POCKET). ABOUT 4CC OF FLUID WAS THEN ASPIRATED. THE PUMP POCKET WAS THEN IRRIGATED BY INJECTING AND ASPIRATING A TOTAL OF 60CC OF SALINE. THE PT WAS ADMITTED TO ICU FOR OBSERVATION OVER THE NEXT 24 HOURS. SHE WAS DISCHARGED THE FOLLOWING MORNING FEELING FINE, BUT WAS AMNESTIC FOR THE FIRST 5 HOURS AFTER THE EVENT. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MARCAINE, CLONIDINE, AND HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention