BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1971019 · Received January 6, 2011

    Report

    Report Number
    3007566237-2011-00102
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD RECENTLY EXPERIENCED INCREASED SPASTICITY. THE PT WAS SEEN IN THE CLINIC ON (B)(6)2010, FOR A ROUTINE REFILL. THE ACTUAL RESIDUAL PUMP VOLUME (25 ML) WAS FOUND TO BE GREATER THAN THE EXPECTED RESIDUAL VOLUME (8.1 ML). THE PUMP EVENT LOGS SHOWED THAT THROUGHOUT THE MONTH OF (B)(6), THE PUMP HAD 4 CONFIRMED MOTOR STALLS. THE MOST RECENT STALL OCCURRED ON (B)(6) 2010, WITH NO RECOVERY RECORDED IN THE EVENT LOGS. A PUMP REPLACEMENT WAS PLANNED. THE PT'S SPASTICITY WOULD BE MANAGED ORALLY. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 500MCG/ML @ 168MCG/DAY. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR EXPLANTED:| CATHETER: MODEL 8731, LOT# N002169801| IMPLANTED: