BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5419331 · Received February 9, 2016

    Report

    Report Number
    3004209178-2016-01767
    Event Type
    Injury
    Date Received
    February 9, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) VIA THE MANUFACTURING REPRESENTATIVE, REGARDING A (B)(6) MALE PATIENT RECEIVING AN UNKNOWN INTRATHECAL MEDICATION VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE OF THE DEVICE WAS FOR NON-MALIGNANT PAIN. THE CONCOMITANT MEDICATIONS AND PATIENT HISTORY WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL WITH SUDDEN WITHDRAWAL. THE PUMP WAS INTERROGATED ON (B)(6) 2016 AND ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 79 MONTHS, ON (B)(6) 2016 THE ERI WAS 38 MONTHS, AND TODAY (B)(6) 2016 THE ERI WAS 19 MONTHS. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT VIA THE MANUFACTURING REPRESENTATIVE REPORTED THAT THE PUMP WAS ENDING LIFE TOO QUICKLY. THE PUMP HAD ONLY BEEN IMPLANTED FOR 2 MONTHS, BUT THE ERI WAS AT 19 MONTHS. THE PATIENT WAS HAVING INCREASED PAIN. NO ACTIONS HAVE BEEN TAKEN. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. THE MEDICAL HISTORY AND PATIENT STATUS WERE UNABLE TO BE OBTAINED. NO SURGICAL INTERVENTION HAD OCCURRED, AND IT WAS UNKNOWN IF IT WAS PLANNED. THE DRUG, ANY DIAGNOSTICS, PATIENT OUTCOME, AND THE CAUSE/ACTIONS/INTERVENTIONS/RESOLUTION RELATED TO THE ERI ISSUE REMAINED UNKNOWN AT THE TIME OF THIS EVENT. FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN THE MISSING INFORMATION; HOWEVER ADDITIONAL INFORMATION RECEIVED PROVIDED NO NEW INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82662 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization