BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3920092 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-12673
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A GEAR TRAIN ANOMALY AND STALL DUE TO SHAFT BEARING, SPECIFIED AS CORROSION, AND/OR WEAR, AND/OR LUBRICATION. (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS WITHDRAWAL AND A PUMP MOTOR STALL OF MODERATE SEVERITY. IT WAS NOTED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ACUTE WITHDRAWAL SYMPTOMS. IT WAS NOTED THEY HEARD AN ALARM ON (B)(6), IT STOPPED, STARTED AGAIN ON (B)(6) AND THEN STOPPED. IT WAS STATED THE LOGS REVEALED A MOTOR STALL ON (B)(6) 2014 AT 00:29 WITH A RECOVERY AT 19:48. IT WAS NOTED THERE WAS IN-PATIENT HOSPITALIZATION, AND UNSCHEDULED CLINIC VISIT, AND AN ER VISIT. IT WAS REPORTED THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. THE PUMP WAS USED TO DELIVER AN UNKNOWN DRUG. ADDITIONAL INFORMATION REPORTED THE PATIENT FELT SICK WITH NAUSEA, HEADACHES, CHILLS AND PAIN ON (B)(6) 2014. IT WAS STATED THEY FELT ¿REALLY BAD¿ ON THURSDAY AND FRIDAY AND CALLED THE HEALTH CARE PROVIDER (HCP) ON SATURDAY. IT WAS NOTED THE PUMP WAS INTERROGATED ON (B)(6) 2014 AND SHOWED NO MORE MOTOR STALLS. IT WAS STATED A DYE STUDY SHOWED THE CATHETER WAS PATENT. THE PUMP WAS USED TO DELIVER COMPOUNDED BACLOFEN AND FENTANYL. ADDITIONAL INFORMATION REPORTED THE PUMP ALARM WAS DUE TO MOTOR STALL. ADDITIONAL INFORMATION REPORTED THERE WAS NO SUPPORT OF THE DEVICE ALARM ON (B)(6) 2014 IN THE ¿NPU¿, ONLY THE MOTOR STALL ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396814 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R