BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 1831107 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03602
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE WAS FOUND TO BE OUTSIDE OF THE EXPECTED LIMITS. THE DEVICE WAS ANALYZED WITH A NEW BATTERY AND WAS FOUND TO BE NORMAL. THE BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION, AND NO ANOMALY WAS DETECTED THAT WOULD CAUSE THE BATTERY TO DEPLETE. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT FROM THE PATIENT NOTIFIER FOR DEVICE AT ERI. THE BATTERY TREND SHOWS THAT THE DEVICE HAD DROPPED OFF DRAMATICALLY. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BYPASS, THE PHYSICIAN ADVANCED AN ETHICON 25MM EEA STAPLER LOADED WITH A 25MM PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX BUTTRESS THROUGH THE UMBILICAL PORT SITE TO THE INTENDED LOCATION OF THE GASTRO-JEJUNAL (GJ) ANASTOMOSIS. UPON ATTEMPTING TO REMOVE THE STAPLER, RESISTANCE WAS ENCOUNTERED WHICH RESULTED IN A GASTRIC TEAR ALONG A COUNTERCLOCKWISE LINE FROM THE 3 O'CLOCK POSITION TO THE 9 O'CLOCK POSITION. THERE WAS NO DIFFICULTY NOTED WHILE LOADING OR FIRING THE STAPLER. IT WAS NOTED THAT THE PHYSICIAN'S REMOVAL TECHNIQUE WAS TO SLIGHTLY PUSH THE STAPLER IN AND ROTATED HIS HAND BACK AND FORTH PRIOR TO ATTEMPTING TO REMOVE THE STAPLER. INSPECTION OF STAPLER AFTER REMOVAL REVEALED THAT THERE WAS ONLY (1) INTACT TISSUE DONUT PRESENT, INSTEAD OF THE USUAL TWO (2). THE PHYSICIAN WAS UNABLE TO SALVAGE THE ANASTOMOSIS, CUT IT OUT, AND MADE A NEW GJ ANASTOMOSIS WITH A NEW 25MM CIRCULAR STAPLER WITH NO BUTTRESSING MATERIAL. THE SECOND ANASTOMOSIS WAS COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT'S CURRENT STATUS WAS REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention