BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2901301 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00291
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 12, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER; PRODUCT ID: 8780, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER WAS EXPLANTED ON (B)(6) 2012 DUE TO THE PATIENT DEVELOPING SYMPTOMS OF URINARY RETENTION AND NEW RADICULAR PAIN SYMPTOMS IN HIS LEG. THE CATHETER SEGMENT WAS DISCARDED AND NOT REPLACED AT THIS TIME. THE HEALTHCARE PROVIDER (HCP) FELT THAT THE SYMPTOMS WERE DUE TO THE RIGIDITY OF THE CATHETER VERSUS THE OLD CATHETER. THE HCP FELT IT WAS DIRECT NERVE ROOT IRRITATION. FOLLOWING THE CATHETER EXPLANT THE RADICULAR SYMPTOMS QUICKLY DISSIPATED; HOWEVER, THE URINARY RETENTION PERSISTED. IT WAS LATER REPORTED THAT ON (B)(6) 2012, A NEW CATHETER IMPLANT TOOK PLACE. THE INITIAL PLACEMENT WAS LEFT SIDED AND THE CATHETER TIP WAS AT T9 SIMILAR TO THE PREVIOUSLY IMPLANTED CATHETER. THE PATIENT WAS AWAKE AND REPORTED WORSENING LEFT LEG PAIN. THE CATHETER WAS MOVED TO A LOWER POSITION AND THE PAIN PERSISTED. THE CATHETER WAS THEN REMOVED AND A NEW CATHETER WAS INSERTED WITH A RIGHT SIDE PLACEMENT. FINAL POSITION IS AT THE TOP OF T12 SLIGHTLY TO THE RIGHT. IT WAS ALSO NOTED THAT THE INITIAL CATHETER REVISION WAS DUE TO A PATIENT FALL CAUSED BY TREMORS FROM A DIAGNOSED MEDICAL CONDITION. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTED BELIEVED THE DEVICE SYSTEM WAS USED TO INFUSE COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9872 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention