BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3150669 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08746
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, LOT# L36201, IMPLANTED: (B)(6) 1995, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP REFILL ON THE (B)(6) 2013 AND AT THAT TIME PUMP LOGS SHOWED ELECTIVE REPLACEMENT INDICATOR (ERI) OF 1 MONTH. THE CALLER DID NOT HEAR ANY ALARMS. BEGINNING AT 4:30AM ON (B)(6) 2013 THE PATIENT SHOWED SYMPTOMS OF LOW BLOOD PRESSURE, LOW HEART RATE AND LOW RESPIRATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE CALLER WAS UNSURE WHAT CAUSED THE SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250678 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization