BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3032970 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04537
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 5, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY AND ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT INDENT IN THE SEAL AND THE INFUSION SYSTEM WAS NOT AFFECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), 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

    CORRECTED INFORMATION: H3: NO EVAL EXPLAIN CODE MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAD EXPERIENCED A LOSS OF EFFECT. IT WAS NOTED THAT THE DOSE WAS BEING WEANED DOWN WITH NO CHANGE SEEN IN THE PATIENT EXCEPT POSSIBLY BEING MORE ALERT. AN INDIUM DYE STUDY WAS PERFORMED, IN (B)(6), AND SHOWED NO FLOW FROM THE PUMP. ADDITIONALLY, A CT SCAN, PERFORMED IN (B)(6), SHOWED A POSSIBLE LEAK AT THE PUMP POCKET. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE FLOW OF CEREBROSPINAL FLUID WAS SEEN FROM THE CATHETER CONNECTOR AND AT THE BACK. THE PATIENT'S PUMP AND CATHETER WERE BOTH REPLACED DUE TO "PRESUMED SYSTEM DYSFUNCTION". IT WAS REPORTED THAT THE PATIENT HAD POSITIVE EFFECT WITH DECREASED SPASTICITY AND HAD RECOVERED WITHOUT SEQUELA. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136686 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention