BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3070383 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01371
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    January 8, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), UDI# (B)(4), PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED AN INCREASE IN PAIN, NAUSEA AND VOMITING AND HAD ASKED FOR PAREGORIC. THE PUMP WAS INTERROGATED AND A REVIEW OF THE LOGS NOTED A MOTOR STALL WAS CONFIRMED TO HAVE OCCURRED ON (B)(6) 2013. THE PUMP STOPPED ON (B)(6) 2013 WITH THE PUMP PERIOD MAY EXCEED TUBE SET MESSAGE ALSO NOTED. THERE WAS NO MOTOR STALL RECOVERY. THE PATIENT STATED HE DID NOT HEAR THE ALARM AND DENIED EXPOSURE TO A MAGNETIC RESONANCE IMAGING (MRI) SCAN. THIS DEVICE SYSTEM DELIVERED DILAUDID AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REPORTED THAT THE PUMP WAS BEEPING AND IT ¿FINALLY QUIT BEEPING AFTER A WHILE". THERE WAS MEDICATION IN THE PUMP, AND THE PUMP BATTERY HADN¿T DEPLETED YET BUT "IT QUIT WORKING". THE PUMP USED TO HAVE DILAUDID BUT THE PUMP WAS CURRENTLY EMPTY. "IT QUIT ON HIM BEFORE THE BATTERY EVER WENT OUT, AND HE WAS SO DISGUSTED HE NEVER WENT BACK TO DO ANYTHING ABOUT". THE CONSUMER THOUGHT THE PATIENT HAD THE FLU, BUT HE HAD WITHDRAWAL. THE DOCTOR CHECKED IT "AND THEY EVEN KNEW THE DATE IT QUIT WORKING". THE CONSUMER COULD NOT REMEMBER THE REASON "IT QUIT" AND COULDN¿T REMEMBER THE DAY THE PUMP STOPPED WORKING. THE PATIENT HAD BEEN FREE OF PAIN FOR THE LAST 3 YEARS, AND THE PAIN SEEMED TO GO AWAY ONCE HE GOT THROUGH THE WITHDRAWAL. THE PATIENT WAS IN HOSPICE CARE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171150 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR