BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3790668 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08519
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT TYPE CHANGED TO ONLY "PRODUCT PROBLEM." "INTERVENTION REQUIRED" WAS MARKED IN ERROR. THIS REPORT IS BEING CORRECTED FROM A "SERIOUS INJURY" TO "MALFUNCTION" AS THE CATHETER ISSUE WAS OBSERVED DURING A PUMP REPLACE MENT AND ADDRESSED AT THAT TIME. ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED. ANALYSIS OF THE CATHETER REVEALED THE DIFFICULTY WITH THE SUTURELESS CONNECTOR LED TO ITS EXPLANT. CONCLUSION: NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS PUMP CONNECTOR DAMAGE WHERE THE SILICON ¿CAME¿ FROM THE METAL INTERNAL PIECE, SO THE CATHETER WAS PARTIALLY EXPLANTED AND REPLACED ON (B)(6) 2014. IT WAS NOTED THEY USED A PIECE FROM A DIFFERENT REVISION KIT. THE PATIENT STATUS WAS NOTED AS ALIVE WITH NO INJURY. THE PUMP WAS USED TO DELIVER MORPHINE. NO PATIENT SYMPTOMS WERE REPORTED WITH THE EVENT. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269446 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention