BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093618 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03474
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    November 2, 2010
    Report Date
    April 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP AND CATHETER HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A FALL ON (B)(6) 2010. THE PT WAS ADMITTED TO THE HOSPITAL AND EXPERIENCED INCREASED BACK PAIN. IT WAS CONFIRMED THROUGH IMAGING THAT THE CATHETER WAS DISLODGED. ON (B)(6) 2010, THE CATHETER WAS REPLACED FOR "ISSUES WITH THE CATHETER" AND THE PUMP REMAINED IN PLACE. ON (B)(6) 2011, THE PT'S ENTIRE DEVICE SYSTEM WAS REPLACED FOR VOLUME DISCREPANCY ISSUES AND ON-GOING CATHETER PROBLEMS. THE ACTUAL RESIDUAL VOLUME WAS 40CC AND THE EXPECTED RESIDUAL VOLUME WAS 30CC. THE PT REPORTEDLY HAD A TOTAL OF THREE CATHETER REVISIONS. THE EXACT DATES OF THESE REVISIONS WERE UNCLEAR. THE HCP WAS NOT ABLE TO WITHDRAWAL CSF (CEREBROSPINAL FLUID) FROM THE CATHETER. IT WAS ALSO STATED THAT THERE WAS "NO EMPTYING OF THE PUMP." THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE SULFATE AND MARCAINE. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N269935002| CATHETER, MODEL 8709SC, LOT#N149967032