BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4152052 · Received October 8, 2014

    Report

    Report Number
    3007566237-2014-02880
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    November 29, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: UPDATED TO REFLECT THE INFORMATION RECEIVED ON 2017-NOV-10. MODEL #/LOT #: UPDATED TO REFLECT THE UDI FOR THE PATIENT'S PUMP. REPORT UPDATED TO REFLECT THE FACILITY CONTACT INFORMATION RELATED TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CLINICAL SPECIALIST (CS) SUPPORTED A REVISION AND THE HEALTHCARE PROVIDER (HCP) NOTED THE CATHETER TIP WAS PREVIOUSLY POSITIONED IN THE CERVICAL SPINE AND HAD BACKED ALL THE WAY OUT OF THE INTRATHECAL SPACE AND DOWN THE SPINE SIGNIFICANTLY. IT WAS UNKNOWN WHEN HIS REVISION SURGERY DATE WAS. THE TYPE OF DRUG BEING DELIVERED BY THE PUMP, THE DATE OF SURGERY, PATIENT SYMPTOMS, AND THE PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE ON 2017-NOV-10. IT WAS REPORTED THAT A REPLACEMENT OF THE CERVICAL CATHETER TIP AT C2-3 IN THE PATIENT'S SPINE OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER MIGRATION/DISLODGEMENT. THE EVENT OCCURRED DURING A PROCEDURE, THE PRODUCT WAS NOTED TO BE THE ANCHOR ON THE CATHETER, AND THE PRODUCT REMAINED IMPLANTED AND IN SERVICE. THE TYPE OF DRUG BEING INFUSED BY THE PUMP SYSTEM WAS UNKNOWN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632896 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention