BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6329230 · Received February 14, 2017

    Report

    Report Number
    3004209178-2017-03818
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 14, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8709SC, LOT# N285283008, IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER .

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING FENTANYL [100 MCG/ML] AT A RATE OF 4.80 MCG/DAY, AND MARCAINE [18 MG/ML] AT A RATE OF 0.864 MG/DAY VIA INTRATHECAL DRUG DELIVERY PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SYNDROME - OTHER. IT WAS REPORTED THAT THE PATIENT HAD A FALL ON (B)(6) 2017 THAT CAUSED THE CATHETER TO FRACTURE. THE DOCTOR WAS AWARE THAT THE PATIENT WAS NOT RECEIVING THE INTENDED/PROGRAMMED INTRATHECAL DOSE DUE TO THE FRACTURED CATHETER. FLOURO SHOTS WERE OBTAINED BY HER MANAGING PHYSICIAN BUT THE DATE WAS UNKNOWN. THE CATHETER REVISION WAS PERFORMED ON (B)(6) 2017. 22 CM OF DISTAL SEGMENT WAS USED AND ATTACHED TO THE CURRENT CATHETER AT THE FRACTURE SITE. THE ISSUE WAS RESOLVED AND THERE WERE NO SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112938 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention