BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5325522 · Received December 23, 2015

    Report

    Report Number
    3004209178-2015-25556
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 4, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND THE BATTERY HAD HIGH RESISTANCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT IN (B)(6) WHO WAS RECEIVING COMPOUNDED BACLOFEN 2000UG /ML AT A DOSE OF 600 MCG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS FOR BILATERAL SEVERE DYSKINETIC CEREBRAL PALSY BASED ON PREMATURITY AND STATUS AFTER INFANT RESPIRATORY DISTRESS SYNDROME (IRDS) GRADE 3 AND SEPSIS. THE LOT NUMBER AND CONCOMITANT MEDICATIONS WERE NOT OBTAINABLE. THE PATIENT'S MEDICAL HISTORY INCLUDED THE FIRST PUMP RECEIVED ON 09-22-2005. A CATHETER REVISION IN (B)(6) 2006 AND IN 2011 A DRAIN DISCONNECTION. THERE WERE NO KNOWN ALLERGIES. A NEW BACLOFEN PUMP AND RECONNECTION DRAIN ON (B)(6) 2011. ON APPROXIMATELY (B)(6) 2015, THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS AND ENTERED THE HOSPITAL. THE LOGS WERE CHECKED AND SHOWED THE PUMP WAS IN SAFE STATE, RESET OCCURRED. IT WAS UNKNOWN IF AN AUDIBLE ALARM WAS HEARD. THE PATIENT WAS ON A DAILY DOSE OF 600 MCG/DAY AND DROPPED TO MINIMUM RATE OF 12,7 MCG. THE PUMP WAS REPROGRAMMED AND UPDATED WITH A SIMPLE CONTINUOUS SETTING OF 600 MCG/DAY. THE PUMP WILL BE EXPLANTED AND REPLACED AS THE NEUROSURGEON WAS TO PERFORM THE PROCEDURE IN "WEEK 50". THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. PATIENT STATUS WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY WHAT WAS MEANT BY A DRAIN DISCONNECTION AND RECONNECTION AND CATHETER REVISION INFORMATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848275 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R