BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2050162 · Received April 1, 2011

    Report

    Report Number
    3004209178-2011-02477
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING A PUMP REFILL PROCEDURE, THE HCP WAS ABLE TO ASPIRATE THE RESERVOIR CONTENTS, BUT WAS UNABLE TO FILL IT. THERE WAS NO VOLUME DISCREPANCY. THE REFILL KIT TUBING WAS PATENT. THERE WAS NO DEPTH ISSUE WITH THE REFILL NEEDLE. THE PUMP DID NOT MOVE AROUND IN THE POCKET. THE HCP FELT METAL ONLY UPON NEEDLE INSERTION INTO THE PUMP. THE HCP INJECTED 5 ML PRESERVATIVE-FREE NORMAL SALINE USING A 5 ML SYRINGE INTO THE PUMP AND THE VALVE WAS "CLEARED." THE HCP WAS THEN ABLE TO ASPIRATE OUT THE 5 ML OF SALINE AND THEN REFILL THE PUMP WITH 30 MLS OF MEDICATION. X-RAYS WERE TAKEN TO VERIFY NEEDLE/PUMP ORIENTATION. IN THE LATERAL VIEW, THE PUMP BELLOWS LOOKED "CROOKED" BUT WAS DIFFICULT TO ASSESS DUE TO ANGLE AND QUALITY OF IMAGES. THE PATIENT DID NOT EXPERIENCE ANY WITHDRAWAL SYMPTOMS. THE PUMP CONTAINED MORPHINE AND BUPIVICAINE.

    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 67 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L39972