BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5568250 · Received April 11, 2016

    Report

    Report Number
    3007566237-2016-01638
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Date of Event
    December 15, 2015
    Report Date
    April 28, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A REPRESENTATIVE REGARDING A PATIENT IN SINGAPORE WHO WAS RECEIVING AN UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP AT THE TIME OF THE EVENT. THE INDICATION FOR USE OF THE IMPLANTED SYSTEM WAS SPASTICITY. THE PUMP LOGS PROVIDED FROM (B)(6) 2016 INDICATED THAT A LOW RESERVOIR OCCURRED ON (B)(6) 2015 AND AN EMPTY PUMP OCCURRED ON (B)(6) 2015. NO PATIENT SYMPTOMS WERE REPORTED AND NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE WHO REPORTED THAT AT THE TIME OF THE EVENT THE IMPLANTABLE PUMP HAD BACLOFEN WITH A CONCENTRATION OF 500.0 G-ML AND DOSE OF 120.07 G/DAY. THE PATIENT'S CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT AVAILABLE AS THE CLINIC DID NOT HAVE ACCESS TO THIS INFORMATION BUT RATHER ONLY THE PHYSICIAN IN CHARGE. THE PATIENT'S CAREGIVER (I.E HER HUSBAND) WAS OVERSEAS AND WAS NOT AVAILABLE TO BRING THE PATIENT DOWN FOR REFILL. THE PATIENT CAME BACK FOR REFILL TWO DAYS AFTER THE EMPTY RESERVOIR PUMP SOUNDED. THE HEALTH CARE PROVIDERS WERE ALL AWARE OF THE EMPTY RESERVOIR NOTICE, AND THEY DID EXPLAIN THE POTENTIAL RISK OF PATIENT MISSING AN REFILL TO HER HUSBAND. HOWEVER THE HUSBAND FELT THAT THE ITB WAS NOT HELPING "HER" WIFE'S CONDITION. NO TROUBLESHOOTING OR DIAGNOSTIC TESTING WAS PERFORMED. THERE WERE ONLY A FEW DROPLETS OF SOLUTION EXTRACTED FROM THE PUMP BEFORE A REFILL WAS DONE. THE PUMP WAS SUCCESSFULLY REFILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222729 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR