BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3790071 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08490
    Event Type
    Injury
    Date Received
    May 5, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8575, LOT # N111789, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT # L71601, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT # N111789, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS DISCONNECTED FROM THE PIN CONNECTOR. IT WAS NOTED THAT A CATHETER COMPLICATION WAS REPORTED. THE REPORTER STATED THE PATIENT WAS IN THE CLINIC AND THEY WERE GOING TO TURN THE PUMP OFF. THE REPORTER FURTHER STATED THE PATIENT WAS ABOUT TO HIT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PATIENT HAD BEEN WEANED OFF. IT WAS NOTED THE CATHETER WAS FOUND TO BE DETACHED FROM THE PUMP BASED ON IMAGING THAT WAS DONE PRIOR TO ROUTINE REPLACEMENT OF THE PUMP. IT WAS FURTHER NOTED THAT AFTER THE CATHETER WAS FOUND TO BE DETACHED THE PATIENT DECIDED THEY WERE NOT GOING TO PURSUE REPLACEMENT OF THE PUMP. THE REPORTER STATED THE CATHETER ISSUE WAS DETECTED IN (B)(6) 2014. THE REPORTER FURTHER STATED THERE WERE NO PATIENT SYMPTOMS. THE PUMP CONTAINED BACLOFEN (COMPOUNDED). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THERE WAS NO REVISION OR REPLACEMENT. SIDE PORT ASPIRATION ATTEMPTED AND FAILED. THE PATIENT¿S DOSE WAS WEANED OFF. NO CHANGE IN SPASM OR SYMPTOMS SO PLAN TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269420 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Required Intervention