BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232648 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02387
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PROXIMAL AND DISTAL CATHETER SEGMENTS REVEALED NO SIGNIFICANT ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8711, LOT# J11212R27, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: PUMP.

    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 THE PATIENT WAS RECEIVING EFFICACIOUS THERAPY. A REPLACEMENT OF THE PUMP WAS DONE FOR EXPECTED END OF LIFE BATTERY. WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP THERE WAS NO RETROGRADE FLOW OF CEREBROSPINAL FLUID (CSF). THEY WERE UNABLE TO WITHDRAW CSF FROM THE CONNECTOR WITH A SYRINGE. THE CATHETER WAS THEN DISCONNECTED AT THE SPINE CONNECTOR SITE WITH SPONTANEOUS RETROGRADE FLOW OF CSF FROM SPINAL CATHETER. THE ORIGINAL SPINAL SEGMENT OF 8711 REMAINS IMPLANTED. THE PUMP SEGMENT OF 8711 WAS EXPLANTED AS WELL AS THE 8596SC CATHETER. IT WAS REPLACED WITH A NEW CATHETER SPLICED ONTO THE EXISTING SPINAL CATHETER SEGMENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. PATIENT STATUS WAS INDICATED AS ALIVE, NO INJURY/NO ADVERSE EVENT. THE PATIENT WAS HOSPITALIZED. POST-OPERATIVELY THE INFUSION RATE WAS DECREASED FROM 479.4 MCG/DAY TO 96 MCG/DAY AND THE PATIENT WAS ADMITTED FOR OBSERVATION. THE PUMP WAS DELIVERING GABLOFEN. IT WAS LATER REPORTED THE HCP BELIEVED THE PATIENT WAS NOT RECEIVING THERAPY AS EXPECTED AFTER THE CATHETER REVISION DONE ON (B)(6) 2013. THE PATIENT HAD A CATHETER IMPLANTED ON (B)(6) 2013 AND THE PROXIMAL SEGMENT WAS EXPLANTED. THE ORIGINAL SPINAL SEGMENT REMAINS IMPLANTED IN PATIENT'S INTRATHECAL SPACE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS SEEN IN BOTH THE PHYSIATRY AND NEUROSURGERY CLINICS ON (B)(6) 2013. THE PATIENT WAS "LOOSER" IN BOTH UPPER AND LOWER EXTREMITIES, MORE COMFORTABLE AND HIGHER FUNCTIONING. THE INFUSION RATE WAS INCREASED FROM SIMPLE CONTINUOUS 330 MCG/DAY TO 360 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335481 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Hospitalization| R