BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2445773 · Received February 10, 2012

    Report

    Report Number
    3004209178-2012-00903
    Event Type
    Injury
    Date Received
    February 10, 2012
    Report Date
    January 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    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

    CATHETER MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(4), EXPLANTED: 2012 (B)(6); CATHETER MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2011 (B)(6); CATHER (PROX REV SEG) MODEL 8596SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(4), EXPLANTED: 2012 (B)(6), CATHETER (PROX REV SEG) MODEL 8596SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2011 (B)(6).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A CSF (CEREBROSPINAL FLUID) LEAK "LAST YEAR"; THE CATHETER WAS REVISED AT THAT TIME. AS OF (B)(4) 2012, THE PATIENT CONTINUED TO HAVE NO THERAPEUTIC EFFECT. THE PLAN WAS TO POSSIBLY REVISE THE CATHETER ON (B)(4) 2012. IT WAS LATER REPORTED THAT PATIENT CONTINUED TO NOT EXPERIENCE ANY RELIEF FROM SPASTICITY AND A (B)(4) STUDY WAS ATTEMPTED, BUT THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THE CATHETER. SURGERY WAS PERFORMED AND A NEW CATHETER WAS IMPLANTED. PER THE REPORTER, THE PATIENT WAS "DOING FINE POST OPERATIVELY". IT WAS LATER REPORTED THE HCP BELIEVED THE CATHETER HAD BROKEN OFF.

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE LOCATION OF BREAK/ISSUE WAS MID CATHETER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention