BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER PAIN PUMP

    MDR report key: 1071565 · Received July 9, 2008

    Report

    Report Number
    MW5007566
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    February 21, 2002
    Report Date
    July 2, 2008
    Manufacturer
    STRYKER
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, RIGHT ARTHROSCOPIC SLAP REPAIR & ACROMIOPLASTY PAIN PUMP PLACED: ONE INTO SUBACROMIAL AND ONE INTO GLENOHUMERAL SPACES. 250 CC OF 0.5% SENSORCAINE W/ EPINEPHRINE 1:200,000 IN PAIN PUMP - TWO PAIN PUMPS INSERTED FOR 500 CC TOTAL. AT THE TIME OF THIS SURGERY, THE ANTEROINFERIOR AND INFERIOR LABRUM, THE ARTICULAR SURFACES AND THE OTHER LIGAMENTOUS STRUCTURES OF THE JOINT WERE IN GOOD CONDITION. ON THE NEXT DAY, ONE OF MY PAIN PUMPS STOPPED WORKING, THE SURGEON PULLED THE CATHETER OUT. ON APPROX TEN MONTHS LATER, DEGENERATIVE ARTHRITIS RIGHT SHOULDER; RIGHT TENODESIS BICEPS, ARTHROSCOPY. THERE WERE DIFFUSE DEGENERATIVE CHANGES OF THE GLENOHUMERAL JOINT. THE HUMERAL HEAD WAS CHARACTERIZED BY GRADE 3 CHANGES, KIND OF GLOBAL. LIKEWISE, THE OPPOSING GLENOID WAS DEGENERATED IN MORE OF A PATCHY FASHION WITH A GRADE 3 DEGENERATIVE CHANGES. THE HUMERAL HEAD WAS CHARACTERIZED BY DEGENERATIVE CHANGES OF A DIFFUSE FASHION. ON 2004, PRE & POST OP DIAGNOSIS: RIGHT SHOULDER DEGENERATIVE ARTHRITIS. OPERATION: RIGHT TOTAL SHOULDER ARTHROPLASTY. DOSE OR AMOUNT: 500 CC, FREQUENCY: UNK, ROUTE: 014, DOSE OF AMOUNT: 330 CC, FREQUENCY: UNK, ROUTE: 014. DATES OF USE: 2002. DIAGNOSIS OR REASON FOR USE: SLAP LESION, DIAGNOSIS OR REASON FOR USE: SHOULDER IMPINGEMENT. IN 2002, STRYKER PAIN PUMP PLACED IN RIGHT SHOULDER JOINT AND SUBACROMIAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PAIN PUMP PAIN MANAGEMENT POST OP PAIN PUMP/JOINT MEB STRYKER UNK UNK
    2 STRYKER PAIN PUMP PAIN MANAGEMENT POST OP PAIN PUMP/SUBACROMIAL MEB STRYKER UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability SENSORCAINE 0.5% W/ EPINEPRINE 1:200| BUPIVACAINE 0.5% W/ EPINEPRINE