BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3760049 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-07543
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    March 31, 2014
    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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004-09-24, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND MISSED A PUMP REFILL. THE PATIENT WAS TO HAVE THE PUMP FILLED EARLY (B)(6) 2014 AND THE REPORTER BELIEVED THEN THAT THE PUMP HAD BEEN EMPTY FOR 6 WEEKS. THE PATIENT WAS GIVEN ORAL OR NASOGASTRIC (NG) BACLOFEN AND IT WAS NOTED THE PATIENT DID NOT APPEAR TO HAVE AN INCREASE IN SPASTICITY. THE PATIENT LATER RETURNED TO GET A REFILL OF THE PUMP. THE PUMP SYSTEM WAS BEING USED TO DELIVER BACLOFEN. IT WAS FURTHER REPORTED THAT THE PATIENT¿S HOSPITALIZATION WAS NOT RELATED TO THE DEVICE OR THERAPY. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 AND THE REPORTER NOTED THAT ORAL BACLOFEN WAS ADEQUATE TO MANAGE. THE PATIENT WAS REFERRED TO NEUROSURGERY FOR EXPLANT. THE LOGS SHOWED THE LOW AND EMPTY RESERVOIR ALARMS HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236795 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention