BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4764904 · Received May 12, 2015

    Report

    Report Number
    3004209178-2015-08911
    Event Type
    Injury
    Date Received
    May 12, 2015
    Report Date
    April 21, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N142172, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE SPINAL LEAKAGE IN (B)(6) OF 2014. THE HEALTH CARE PROVIDER (HCP) ATTEMPTED IN (B)(6) OF 2015 TO STOP THE LEAKAGE THROUGH SURGERY AND IT DID NOT STOP. THE HCP WENT BACK IN AGAIN A SECOND TIME IN (B)(6) OF 2015 AND ¿REMOVED THE PUMP.¿ IT WAS NOTED THAT ¿THEY JUST REINSERTED THE PUMP NOW.¿ THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT¿S SYMPTOMS, INTERVENTIONS, AND OUTCOME, BUT WAS NOT AVAILABLE AT OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309754 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention