BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7925706 · Received October 2, 2018

    Report

    Report Number
    3004209178-2018-22023
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    May 8, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530119
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 26-MAR-2020, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING DURAMORPH (5 MG/ML AT 0.3516 MG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THAT THE CATHETER MAY HAVE BEEN RESTING ON THE PATIENT'S SCIATIC NERVE CAUSING HER DISCOMFORT SO A REVISION WAS PERFORMED TO MOVE THE CATHETER. THE CALLER STATED THAT THEY REVISED THE SPINAL SEGMENT OF THE CATHETER. THE NEW CATHETER LENGTH (63.4 - 20 = 43.4 + 31.4 = 74.8 + 27.9 = 102.7 CM) AND VOLUME (31.4 X .0022 = .069 ML) WERE REPORTED. NO FURTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765910 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169530119

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention