BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3853857 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10259
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 15, 2014
    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

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES, NORMAL DEVICE FUNCTION. ANALYSIS OF THE RETURNED CATHETERS ALSO INDICATED NO SIGNIFICANT ANOMALIES, ACCEPTABLE CATHETER TESTING. THE RETURNED 8709SC (LOT# N247722009) CATHETER WAS DEFORMED IN SHAPE AND/ OR ABRASION WAS NOTED, HOWEVER THIS DID NOT AFFECT INFUSION, CONCLUDED AS NON-SIGNIFICANT ANOMALIES, ACCEPTABLE CATHETER TESTING. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT# N247722009, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT# N166551, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (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

    IT WAS REPORTED THAT THERE WAS AN UNKNOWN OR OTHER PRODUCT ISSUE SPECIFIED AS THE PATIENT WAS NOT GETTING SPASTICITY RELIEF. IT WAS NOTED THAT THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDE SURGICAL INTERVENTION EXPLAINED AS A CATHETER REVISION ON (B)(6) 2014. IT WAS REPORTED THAT THERE WAS A DYE STUDY AND ROTOR/ROLLER STUDY PERFORMED. IT WAS NOTED THAT THERE WAS AN UNKNOWN OR OTHER PRODUCT ISSUE SPECIFIED AS ¿A CONNECTOR; MAY OR MAY NOT BE PART OF ISSUE¿. IT WAS REPORTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE ¿ NO INJURY. IT WAS NOTED THAT THE PATIENT HAD INCREASED SPASTICITY AT AN UNKNOWN LOCATION. IT WAS REPORTED THAT THE PUMP WAS USED TO INFUSE LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332745 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention