BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1001532 · Received February 21, 2008

    Report

    Report Number
    6000030-2008-00821
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY FOLLOWING A PUMP REPLACEMENT THE PT REPORTED AN EPISODE OF APNEA AND APPEARED TO HAVE HAD A NARCOTIC OVERDOSE. THE PT WAS ADMITTED TO THE ICU. THE HCP CITED SEVERAL POSSIBILITES FOR THE PT'S OVERDOSE INCLUDING A FLUSH PERFORMED WHILE CHECKING THE CATHETER, A BOLUS DELIVERED AFTER THE REPLACEMENT, PERHAPS THEY SHOULD HAVE ESTIMATED THE CATHETER LENGTH MORE CONSERVATIVELY, OR THAT THE PT MAY HAVE BEEN EXPERIENCING A SLOW LEAK DUE A HOLE IN THE CATHETER THAT WAS CORRECTED DURING THE PUMP REPLACEMENT LEADING TO OVERDOSE WHEN THERAPY WAS RESUMED. NO PT OUTCOME WAS REPORTED. THE PT'S PUMP CONTAINED MORPHINE. REFERENCE MFR REPORT # 2182207200800822.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC VASCULAR CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE INFUSION: PUMP MODEL 8637-40| LOT#NGV410710H| EXPLANTED:| IMPLANTED: