BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6282804 · Received January 27, 2017

    Report

    Report Number
    3004209178-2017-01890
    Event Type
    Injury
    Date Received
    January 27, 2017
    Report Date
    March 21, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE NO LONGER APPLIES. PATIENT CODE NO LONGER APPLIES. ALL OTHER CODES REMAIN. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN AT A DOSE OF 96 MCG VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE HCP WAS GOING TO EXPLANT THE PATIENT¿S PUMP ON (B)(6) 2017 DUE TO EROSION AND PRESSURE. IT WAS NOTED THE PATIENT HAD LOST A LOT OF WEIGHT. THE HCP HAD THE DOSE DOWN TO 96 MCG; THEY WOULD LIKE IT AS LOW AS POSSIBLE. THE GOAL WAS TO RE-IMPLANT ON THE OTHER SIDE IN 2 MONTHS ONCE THE PATIENT ¿FATTENS UP." ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS ON CLONAZEPAM AND BACLOFEN ¿5 MG PO Q HS¿ [INTERPRETED AS 5 MG BY MOUTH, EVERY DAY, AT BEDTIME]. THE HCP WAS CONCERNED THAT THE ORAL BACLOFEN WOULD POSSIBLY MAKE THE PATIENT TOO DROWSY, SO THEY WOULDN'T LET THE PATIENT DRIVE THEIR WHEELCHAIR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED DUE TO AN INFECTION AND THE HCP WAS PLANNING TO RE-IMPLANT THE PATIENT ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66034 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention