BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2855091 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11096
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 4, 2012
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND CORROSION, WEAR, AND RESIDUE ON THE GEAR-TRAIN AND PUMP-HEAD.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2012 MOTOR STALL OCCURRED. (B)(6) 2012 STOPPED PUMP PERIOD MAY EXCEED TUBE SET. 2015-03-26 LFC (HCP) ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE PATIENT REPORTED HAVING INCREASING AMOUNT OF PAIN. THE PUMP HAD BEEN ALARMING. THE PATIENT WAS QUITE CONCERNED THAT THE PUMP WAS NOT WORKING AS THE CODE INDICATED THAT THE PUMP HAD STOPPED WORKING. TELEMETRY WAS PERFORMED AND IT WAS CLEARLY NOTED THAT THE PATIENT HAD A PROBLEM WITH THE PUMP. IT INDICATED THAT A MOTOR STALL HAD OCCURRED. (OMITTED INFORMATION (B)(4) WEIGHT CHANGE/REVISION).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE PATIENT REPORTED HAVING INCREASING AMOUNT OF PAIN. THE PUMP HAD BEEN ALARMING. THE PATIENT WAS QUITE CONCERNED THAT THE PUMP WAS NOT WORKING AS THE CODE INDICATED THAT THE PUMP HAD STOPPED WORKING. TELEMETRY WAS PERFORMED AND IT WAS CLEARLY NOTED THAT THE PATIENT HAD A PROBLEM WITH THE PUMP. IT INDICATED THAT A MOTOR STALL HAD OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL WITHOUT RECOVERY, THE PATIENT EXPERIENCED WITHDRAWAL AND THE PUMP WAS SUBSEQUENTLY REPLACED. THE PATIENT INITIALLY REPORTED HEARING THE ALARM AND GETTING THE 8476 MOTOR STALL CODE ON THEIR PERSONAL THERAPY MANAGER (PTM) DEVICE. THE PATIENT DID NOT HAVE MRI AND WAS NOT EXPOSED TO ANY MAGNETS. THE PATIENT NOTED BEING IN A LOT OF PAIN, BUT HAD BEEN FOR A WHILE, SO IT WAS UNKNOWN IF THERE WAS ANY DIFFERENCE AT THE TIME. IT WAS REPORTED THE NEXT DAY THAT THE MOTOR STALL WAS CONFIRMED BY TELEMETRY TO HAVE STALLED ON (B)(6) 2012, AND THERE WAS NO RECOVERY. THE REPORTER NOTED THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) STILL HAD 36 MONTHS. THE PATIENT WAS AT THAT TIME HAVING WITHDRAWAL SYMPTOMS, AND THE PUMP WAS THEN REPLACED ON (B)(6) 2012. PATIENT STATUS AND OUTCOME WERE NOT PROVIDED. THE MEDICATIONS BEING DELIVERED VIA THE PUMP WAS SUFENTANIL, BUPIVACAINE, PRIALT AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention