BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3770628 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08073
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 3, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S CATHETER WAS REPLACED ON (B)(6) 2014. THE REPORTER STATED THE PATIENT WOULD HAVE AN MRI TO RULE OUT ¿SCI¿ POSSIBLY SECONDARY TO CATHETER REVISION. IT WAS NOTED THAT MEDICAL INTERVENTION AND HOSPITALIZATION WERE REQUIRED. IT WAS NOTED THE PATIENT HAD LEG WEAKNESS AND THEY HAD A HISTORY OF LEG WEAKNESS WITH THE RIGHT LEG WORSE THAN THE LEFT LEG. IT WAS FURTHER NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PUMP CONTAINED MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THE LEG WEAKNESS WAS UNRELATED TO THE PUMP AND CATHETER. IT WAS NOTED THE PATIENT HAD ARACHNOIDITIS PRIOR TO THEIR FIRST PUMP. THE REPORTER STATED THE PATIENT¿S CATHETER HAD BEEN CUT ON ACCIDENT BY THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) LAST YEAR. THE REPORTER FURTHER STATED THAT THE DEVICE ISSUE WAS NOT CONSIDERED RESOLVED FOLLOWING THE CATHETER REPLACEMENT. IT WAS NOTED THAT NO FURTHER TROUBLESHOOTING HAD BEEN DONE. IT WAS FURTHER NOTED THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249724 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R