BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802356 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08784
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 8, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER(B)(4). ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALIES, INCLUDING CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHAFT BEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MULTIPLE MOTOR STALLS OCCURRED. PER PUMP LOGS FROM (B)(6) 2014, ON (B)(6) 2014, A STALL AT 7:35AM WITH A RECOVERY AT 9:50AM, A STALL AT 5:04PM WITH A RECOVERY AT 5:17PM, A STALL AT 5:45PM WITH A RECOVERY AT 7:08PM, AND A STALL AT 7:34PM WITH A RECOVERY AT 8:29PM OCCURRED. TWO DAYS LATER, A STALL AT 6:45PM OCCURRED WITH A TUBE SET MESSAGE ON (B)(6) 2014 AT 6:45PM. NO MOTOR STALL RECOVERY WAS LOGGED. THE PATIENT EXPERIENCED INCREASED PAIN AND NAUSEA BEGINNING ON (B)(6) 2014. A PUMP REPLACEMENT OCCURRED. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN, FENTANYL, KETAMINE AND SUFENTANYL. IT WAS LATER REPORTED THAT THE PATIENT DID NOT HAVE AN MRI AND THE CAUSE OF THE STALL IN (B)(6) WAS UNKNOWN. AS OF (B)(6) 2014, THE PATIENT WAS DOING FINE AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281905 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention