BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021327 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04233
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 26, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTH CARE PROVIDER (HCP) WAS SEEING THE PATIENT FOR THE FIRST TIME, AND THEY NOTED THAT ON (B)(6) 2013, THE PATIENT'S LAST PROVIDER SET THE PUMP TO "STOPPED." IT HAD BEEN STOPPED FOR 985 HOURS (41 DAYS). THE NEW PROVIDER THOUGHT IT WAS BECAUSE THE PATIENT WANTED IT EXPLANTED. THE PATIENT DID NOT LIKE THE AESTHETICS OF THE PUMP, SO THE HCP THOUGHT IT WAS GOING TO BE EXPLANTED, BUT WAS UNSURE WHY THE PUMP WAS NOT SET TO MINIMUM RATE RATHER THAN STOPPING IT. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED TO BE IN 50 MONTHS. IT WAS THE UNDERSTANDING OF THE HCP THAT 24 TO 48 HOURS AFTER THE PUMP WAS STOPPED, THE PATIENT WENT INTO WITHDRAWAL AND WAS ADMITTED TO THE HOSPITAL WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. THE PUMP SYSTEM WAS DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123271 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization