BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193306 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05377
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    October 26, 2010
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z #0592-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A MOTOR STALL WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2010 WITH A 48 HOUR TUBE SET MESSAGE ON (B)(6) 2010. PT WAS LAST FILLED WITH NORMAL SALINE ON (B)(6) 2010 AND HAD PREVIOUSLY BEEN INFUSING LIORESAL 500MCG/ML. PT HAD AN MRI ON (B)(6) 2010 (REASON UNK). PT HAD BEEN IN HYPERBARIC CONDITIONS UP TO 1075 ATA SINCE THE LAST REFILL ON (B)(6) 2010. HCP INTERROGATED PUMP ON (B)(6) 2011 AND SAW THE MOTOR STALL ATTENTION DIALOG BOX. ON PROGRAMMING OF A SINGLE BOLUS AND RE-INTERROGATION A MOTOR STALL RECOVERY WAS NOTED. CURRENTLY THE PUMP WAS FUNCTIONING AS PROGRAMMED. THE PUMP WAS INFUSING SALINE 0.5ML/DAY. THERE WERE NO CURRENT PT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT #N127914006| CATHETER: MODEL 8731SC, LOT #N134269004| IMPLANTED:| IMPLANTED: