BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061967 · Received April 5, 2011

    Report

    Report Number
    3007566237-2011-02607
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HEARD A PUMP ALARM AND WENT INTO THE CLINIC. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING; ALARM DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE HCP WAS UNABLE TO ASPIRATE ANY DRUG FROM THE PUMP. THE PATIENT WAS A LITTLE LIGHT-HEADED. THE PROGRAMMER SHOWED THAT 22.6 ML HAD BEEN DISPENSED SINCE THE LAST REFILL ON (B)(6) 2011; THE PATIENT WAS NOT DUE FOR ANOTHER REFILL FOR 2 MORE MOTHS. THE HCP FILLED THE PUMP WITH 10 ML AND COULD NOT GET ANYMORE IN. THE HCP TRIED THE LOCKED VALVE PROCEDURE AND ASPIRATED 15 ML. THE HCP WAS THEN ABLE TO FILL THE PUMP WITH 20 ML AND UPDATE THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN AT 88 MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596, LOT# N075025011| CATHETER: MODEL 8709, LOT# N074434025