BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3833467 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09640
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 7, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, 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

    ANALYSIS OF THE PUMP FOUND A SIGNIFICANT ANOMALY. IT WAS DETERMINED THROUGH ANALYSIS THAT THERE WAS A GEAR TRAIN ANOMALY IN THE MOTOR DUE TO CORROSION/WEAR/LUBRICATION. IT WAS ALSO DETERMINED THAT THERE WAS A GEAR TRAIN ANOMALY IN THE MOTOR FROM A STALL DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP SYSTEM WAS EXPLANTED, REPLACED, AND REPROGRAMMED DUE TO A MOTOR STALL WHOSE RECOVERY WAS MORE THAN TWO HOURS AFTER THE STALL. THE PATIENT WAS REPORTEDLY NOT EXPOSED TO ANY MAGNETS. THE PARENTS REPORTEDLY HEARD A CRITICAL ALARM AND IMMEDIATELY CONTACTED THE MANAGING PHYSICIAN WHO INSTRUCTED THE PARENTS TO START ORAL ANTI-SPASMOTICS AND TO BRING THE PATIENT INTO THE HOSPITAL. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC FOR WITHDRAWAL AT ANY POINT IN THE TIME SINCE THE INITIAL MOTOR STALL. THE PUMP LOGS SHOWED A MOTOR STALL ON (B)(6) 2014 AT 1:24 AND A RECOVERY ON (B)(6) 2014 AT 16:28. ANOTHER MOTOR STALL WAS NOTED ON (B)(6) 2014 AT 1:14 AND WAS STILL STALLED WHEN THE PUMP WAS REPLACED ON (B)(6) 2014 AT 9:00. THE PATIENT WAS REPORTEDLY ALIVE WITH NO INJURY AT THE TIME OF REPORT. THE PUMP WAS INFUSING BACLOFEN. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT YET DETERMINED. THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF THE PUMP. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED BACLOFEN WITHDRAWAL, SPECIFICALLY GABLOFEN. THE REPORTED SYMPTOMS WERE AGITATION AND MILD HEADACHE. THE SEVERITY OF THE EVENT WAS REPORTED TO BE MILD AND RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE EVENT REPORTEDLY RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. FURTHER DETAILS WERE PROVIDED REGARDING THE ONSET. A TWO TONE ALARM HAD BEEN HEARD EVERY 20 MINUTES BY THE PATIENT AND CAREGIVER ON (B)(6) 2014. IT WAS NOTED THAT THERE WAS A MOTOR STALL RECOVERY LOGGED AT 14:58 ON (B)(6) 2014. IT WAS NOTED THAT THE ETIOLOGY WAS RELATED TO THE PUMP DEVICE OR THERAPY. IT WAS UNLIKELY RELATED TO THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310641 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R