BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2821826 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09980
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND A PUMP MOTOR GEAR TRAIN ANOMALY/CORROSION AND/OR WEAR AND/OR LUBRICATION. THERE WAS RESIDUE FOUND ON THE GEARS. FINAL ANALYSIS OF THE CATHETER FOUND DAMAGE OCCURRED TO THE CATHETER AND ALSO TO CATHETER BODY AND/OR GUIDEWIRE DURING IMPLANT PROCEDURE. THERE WAS ALSO DIFFICULTY WITH THE CATHETER AND GUIDEWIRE INTERACTION. THERE WAS A CUT AND A HOLE ON THE CATHETER BODY, WHICH HAD AN APPEARANCE WHICH INDICATED IT TO BE A RESULT OF DAMAGE THAT OCCURRED DURING THE GUIDEWIRE REMOVAL AT IMPLANT. EVAL - CONCLUSION - APPLIES TO THE CONCOMITANT PRODUCT/CATHETER <(>&<)> APPLIES TO THE PUMP DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO A MOTOR STALL THAT NEVER RECOVERED. ON (B)(6) 2012, TELEMETRY INITIALLY CONFIRMED A CRITICAL ALARM OCCURRED DUE TO MOTOR STALL. THE PUMP LOG VERIFIED THE STALL WAS CONSTANT AND DISPLAYED THE ERROR "STOPPED PUMP MAY EXCEED TUBE SET". THE CRITICAL ALARM HAD BEEN AUDIBLE SINCE (B)(6) 2012. THE REPORTER DENIED ANY EXPOSURE TO AN MRI. IT WAS THEN LATER REPORTED THAT THE PUMP WAS EXPLANTED ON (B)(6) 2012 DUE TO THE MOTOR STALL NOT EVER RECOVERING. BOTH THE PUMP AND CATHETER WERE RETURNED FOR ANALYSIS; HOWEVER, THE ONLY INFORMATION REPORTED REGARDING THE CATHETER WAS THAT THERE WAS A "POSSIBILITY OF CATHETER NOT BEING IN THE INTRATHECAL SPACE". NO SPECIFIC ALLEGATION OR REASON FOR REPLACEMENT WAS PROVIDED. REPORTER STATED AFTER THE PROCEDURE, THE PATIENT RECOVERED WITHOUT SEQUELAE. THE MEDICATIONS IN THE PUMP WERE LIORESAL (BACLOFEN), CLONIDINE, AND MORPHINE. 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 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention