BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3130594 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08202
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 19, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A CATHETER REVISION OCCURRED; HOWEVER, THE DATE OF THE REVISION WAS NOT PROVIDED. THE PATIENT REQUIRED HOSPITALIZATION. PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S CATHETER WAS SUSPECTED TO HAVE MIGRATED AND/OR BECOME DISLODGED. THE PATIENT HAD CONTACTED THE HEALTHCARE PROVIDER (HCP) WITH A REPORT OF ¿SWELLING OVER THE UPPER LUMBAR REGION AND SWELLING AROUND THE PUMP IN THE RIGHT LOWER QUADRANT.¿ THE PATIENT DENIED FEVER OR CHILLS AND HAD NO HEADACHE OR NEW WEAKNESS. THE TONE IN THE PATIENT LEGS FELT ¿TIGHTER THE LAST FEW WEEKS.¿ THE PATIENT HAD FALLEN TWICE AT HOME IN LATE (B)(6) 2013. THE PATIENT EXPERIENCED SYMPTOMS OF INCREASED SPASTICITY AND SEROMA. THE MANAGING HCP DOCUMENTED A LARGE SEROMA AROUND THE INTRATHECAL PUMP IN THE RIGHT LOWER QUADRANT OF THE ABDOMEN. THERE WAS NO ERYTHEMA OR TENDERNESS. IT WAS ALSO INDICATED THAT UPON EXAMINATION THE PATIENT¿S SPEECH WAS SLIGHTLY DYSARTHRIC, THERE WAS SOFT FLUID SWELLING OVER THE UPPER LUMBAR SCAR, GAIT WAS WIDE BASED, AND THERE WAS PROXIMAL WEAKNESS DUE TO TONE ON THE LEFT SIDE. A CATHETER DYE STUDY WITH FLUORO WAS PLANNED FOR (B)(6) 2013. PATIENT OUTCOME WAS REPORTED AS WITH INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS CATHETER MIGRATION POST 3 PATIENT FALLS. THE CATHETER DYE STUDY AS WELL AS AN X-RAY WAS PERFORMED ON (B)(6) 2013. THE RESULTS OF THE DYE STUDY SHOWED THAT THE CATHETER HAD MIGRATED OUT OF THE INTRATHECAL SPACE. THE PATIENT EXPERIENCED INCREASED TONE IN THE LOWER EXTREMITIES BUT SHOWED NO SIGNS OR SYMPTOMS OF BACLOFEN WITHDRAWAL. A SURGICAL INTERVENTION/REVISION WAS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232189 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R