BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8662680 · Received June 3, 2019

    Report

    Report Number
    3004209178-2019-10688
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED THE PATIENT'S TDD SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THE SYSTEM WAS DISCARDED BY THE CUSTOMER. THE DATE OF THE SYSTEM EXPLANT WAS NOT KNOWN. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456347 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention