BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3894059 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12021
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALY, CORROSION AND OR WEAR AND OR LUBRICATION, FEEDTHRU ANOMALY, SHORTING ACROSS INSULATOR, GEAR TRAIN ANOMALY STALL DUE TO SHAFT-BEARING. PUMPHEAD PUMP TUBE INTEGRITY ANOMALY, UNCONFIRMED PUMP TUBE BREACH. THE INSIDE OF THE PUMPHEAD COMPARTMENT, AND MOTOR CAN, HAD RESIDUE AND FLUID PRESENT. A LEAKING PUMP TUBE WAS SUSPECTED, BUT THE LEAK COULD NOT BE FOUND OR REPRODUCED. IT IS BELIEVE THE LEAK HAD ¿SELF HEALED.¿

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WITH NO MOTOR STALL RECORDED IN THE EVENT LOGS WAS REPORTED. THE REPORTER WAS ASKED TO COME TO THE CLINIC THE DAY OF THE REPORT TO DO SOME TROUBLESHOOTING ON THE PATIENT¿S PUMP DUE TO MOTOR STALLS. THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES (B)(6) 2014. THE LAST MOTOR STALL HAD NOT RECOVERED WAS (B)(6) 20/14 2339 AND TUBE SET (B)(6) 2014 2339. THE PATIENT DID HAVE CARPEL TUNNEL SURGERY 5/31/14 UNDER LOCAL ANESTHESIA. THE REPORTER DENIED ANY EMI OR MAGNETIC INTERACTION, I.E., MRI. THE PATIENT WAS COMPLAINING OF RETURN OF SYMPTOMS, INCREASED PAIN. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION LATER REPORTED THE PUMP WAS EXPLANTED. ADDITIONAL INFORMATION LATER REPORTED THE STALL DID NOT RECOVER AND NO CAUSE OF THE STALLS DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371088 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention