BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3286800 · Received August 14, 2013

    Report

    Report Number
    3004209178-2013-14579
    Event Type
    Injury
    Date Received
    August 14, 2013
    Report Date
    July 18, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; P] RODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 WERE HIGH RESIDUAL VOLUMES AT THE TWO PREVIOUS REFILLS. 28.5 ML HAD BEEN EXPECTED WHEN THE ACTUAL VOLUME IN THE PUMP WAS 40ML. THE CAUSE OF THE VOLUME DISCREPANCY WAS REPORTEDLY UNKNOWN. THE PATIENT WAS RECEIVING SUBOPTIMAL THERAPY, PAIN, INCREASED SPASTICITY AND LESS THAN 50% THERAPY RELIEF. THE PATIENT HAD BEEN BROUGHT TO THE OPERATING ROOM FOR A PUMP REPLACEMENT BECAUSE THE MANAGING ADVANCED PRACTICE NURSE (APN) HAD SEVERAL VOLUME DISCREPANCIES ON REFILLS. THE LAST REFILL HAD BEEN 4.5ML VERSUS 35ML LEFT. THE APN WANTED BOTH THE PUMP AND CATHETER REPLACED. IT WAS ALSO NOTED THE HEALTH CARE PROVIDER AND APN FELT IT WAS A CATHETER ISSUE. DIAGNOSTIC TESTING OR TROUBLESHOOTING INCLUDED CHECKING THE LOGS AND X-RAYS. THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THE CATHETER AT TIME OF REPLACEMENT. IT WAS REPORTED THAT A CATHETER OCCLUSION WAS FOUND AT AN UNKNOWN LOCATION OF THE CATHETER. THE PUMP AND CATHETER WERE EXPLANTED AS THE APN WAS CONCERNED THERE COULD BE A PUMP ISSUE DUE TO THE VOLUME DISCREPANCIES. IT WAS REPORTED THE IMPLANTER ATTEMPTED TO PLACE A NEW CATHETER FOR OVER 6 HOURS BUT WAS UNABLE TO GET A NEEDLE INTRATHECAL AND WAS UNABLE TO REPLACE THE CATHETER AFTER THE LONG EXTENSIVE SURGERY. IT WAS NOTED THE PATIENT HAD SEVERE SCOLIOSIS. THE PATIENT WAS TO UNDERGO ANOTHER SURGERY FOR PLACEMENT OF RODS TO STRAIGHTEN THE SCOLIOSIS. IT WAS BELIEVED THE AGREEMENT WAS THAT THE PATIENT WOULD THEN HAVE A NEW PUMP PLACED AFTER THAT WAS COMPLETED. THE CATHETER WAS DISCARDED AND WOULD NOT BE RETURNED. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390851 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention