BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 6116344 · Received November 21, 2016

    Report

    Report Number
    3004209178-2016-24415
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    August 4, 2016
    Report Date
    December 22, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 CONSUMER REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND POST SPINAL CORD INJURY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2016 DUE TO SEPSIS. THE DEVICE WAS REMOVED APPROXIMATELY TWO WEEKS PRIOR TO PASSING DUE TO A MAJOR INFECTION AT SITE. THE HEALTHCARE PROVIDER (HCP) TURNED THE PUMP DOWN PRIOR TO REMOVAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE PATIENT HAD BEEN REFILLED ON (B)(6) 2016. THE PUMP WAS E XPLANTED (B)(6) 2016. THE PATIENT PASSED AWAY IN THE HOSPITAL. THE PATIENT DEVELOPED AN ABSCESS OVER HIS PUMP AFTER ONE WEEK OF HOSPITALIZATION FOR UROSEPSIS. THERE WAS NO DEVICE ISSUE, THERAPY ISSUE OR PROCEDURE ISSUE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING. THE CAUSE OF THE INFECTION AT THE SITE WAS UNKNOWN. THE INFECTION DID NOT RESOLVE PRIOR TO THE PATIENT PASSING ON (B)(6) 2016. THE PATIENT¿S ADMITTING DIAGNOSIS TO THE HOSPITAL WAS UROSEPSIS WITH TRACHEITIS. TESTING DONE TO CONFIRM THE INFECTION INCLUDES (B)(6) 2016 92% GRANULOCYTES. (B)(6) URINALYSIS (UA) GREATER THAN 37 WHITE BLOOD CELLS (WBC) LARGE LEUKOCYTES 2+ BACTERIA (B)(6) 2016 QTL POSITIVE FOR PSEUDOMONAS SENSITIVE MARCESCENS AND AGAIN ON (B)(6) 2016. (B)(6) POCKET FLUID POSITIVE CULTURE FOR STREPTOCOCCUS VIRIDANS PAN SENSITIVE (B)(6) LUMBAR PUNCTURE (LP) CEREBROSPINAL FLUID (CSF) PROTEIN 189 GLUCOSE 71 (B)(6) POCKET FLUID POSITIVE FOR STREPTOCOCCUS DYSGALACTIAE (B)(6) BLOOD CULTURE CONG- STAPHYLOCOCCUS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768571 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| R