BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD - DISPOSABLE

    MDR report key: 1413445 · Received July 9, 2009

    Report

    Report Number
    6000001-2009-00644
    Event Type
    Injury
    Date Received
    July 9, 2009
    Date of Event
    April 28, 2006
    Report Date
    June 23, 2009
    Manufacturer
    UNK
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL CLINICAL INFORMATION FROM THE FACILITY, HOWEVER, THE FACILITY DECLINES TO PROVIDE ADDITIONAL INFORMATION. THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN, THEREFORE, NO EVALUATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    THE LEGAL DEPARTMENT RECEIVED A CUSTOMER REPORT, LAWSUIT, OF PERSONAL INJURIES DUE TO AN UNIDENTIFIED PAIN PUMP ALLEGEDLY MANUFACTURED BY BAXTER. THE PATIENT UNDERWENT ARTHROSCOPIC SHOULDER SURGERY ON HER RIGHT SHOULDER IN 2006. FOLLOWING THE PROCEDURE, A POSTOPERATIVE "PAIN PUMP" WAS IMPLANTED INTO HER SHOULDER BY HER ORTHOPEDIC SURGEON. THE PAIN PUMP INJECTED A PAIN RELIEF MEDICATION, ASTRA ZENECA DRUG BUPIVACAINE, DIRECTLY INTO THE PATIENT'S GLENOHUMERAL SHOULDER JOINT ON A CONTINUOUS BASIS FOLLOWING SURGERY. THE PATIENT ALLEGES THAT AS A RESULT OF THE PAIN PUMP AND PAIN RELIEF MEDICATION, THE PATIENT HAS SUFFERED SEVERE AND RAPID LOSS OF ARTICULAR CARTILAGE IN HER RIGHT SHOULDER, RESULTING IN A CHONDROLYSIS, LOSS OF RANGE OF MOTION, LOSS OF FUNCTIONAL USE OF HER ARM, A TOTAL SHOULDER REPLACEMENT AND SEVERE AND PERMANENT PAIN AND SUFFERING AS WELL AS OTHER UNSPECIFIED INJURIES. ADDITIONAL INFORMATION HAS DETERMINED THAT THE PUMP IN QUESTION IS THE MULTIRATE INFUSOR PUMP BY ZIMMER, INC. DESIGNED, MANUFACTURED, MARKETED AND DISTRIBUTED A PRODUCT CALLED "PAIN PUMP", WHICH IS A MEDICAL DEVICE THAT DELIVERS, VIA A CATHETER IMPLANTED UNDER THE SKIN, A CONTINUOUS DOSE OF PAIN RELIEF MEDICATION DIRECTLY INTO THE GLENOHUMERAL SHOULDER JOINT. ZIMMER INC AND BAXTER HAVE A QUALITY AGREEMENT IN WHICH ZIMMER INC. DISTRIBUTES THE BAXTER MULTIRATE INFUSOR PUMP PRODUCTS. IT IS UNKNOWN WHICH OF THESE PRODUCT CODES IS ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE UNKNOWN MEB UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention