BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1900910 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04925
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIRS OF TWO INFUSOR LV 5 DEVICES WERE LEAKING DURING FILLING. THIS IS REPORT NUMBER 2 OF 2. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    LITERATURE: FAUCHERON JL, VOIRIN D, BADIC B. SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE: CAUSES OF SURGICAL REVISION FROM A SERIES OF 87 CONSECUTIVE PTS OPERATED ON IN A SINGLE INSTITUTION. DIS COLON RECTUM. NOV 2010;53(11):1501-1507. SUMMARY: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE CAUSES OF SURGICAL REVISION FOLLOWING SACRAL NERVE STIMULATION IN CONSECUTIVE PTS WHO HAD RECEIVED IMPLANTS. FROM (B)(6) 2001 TO (B)(6) 2009, 123 PTS (I05 WOMEN) OF MEAN AGE (B)(6) WERE OPERATED ON FOR NEUROLOGICAL (N=104) OR IDIOPATHIC (N=19) FECAL INCONTINENCE. EIGHTY-SEVEN PTS OF 123 HAD A POSITIVE TEST AND UNDERWENT STIMULATOR IMPLANTATION. ANY STIMULATOR DYSFUNCTION WAS PROSPECTIVELY STUDIED. AMONG THE 87 PTS, 36 HAD SURGICAL REVISION OF THE DEVICE FOR THE FOLLOWING REASONS: DEVICE-RELATED FAILURE DUE TO INFECTION, ELECTRODE DISPLACEMENT OR BREAKAGE, AND DYSFUNCTION OWING TO IMPEDANCE INCREASE OF THE SYSTEM; ADVERSE STIMULATION WITH PAIN; BATTERY DEPLETION EITHER OF GENERATOR END OF LIFE OR MRI; AND LOSS OF CLINICAL EFFICACY. AMONG THE 87 PTS, 21 HAD REMOVAL OF THE STIMULATOR DURING FOLLOW-UP. REPORTABLE EVENT: IT WAS REPORTED THAT ONE PT (A (B)(6) FEMALE) FELT THAT THE STIMULATOR WAS TOO SUPERFICIAL AND FELT PAIN AND ASKED FOR REPOSITIONING UNDER THE MUSCULAR APONEUROSIS AT 9 MONTHS WITH AN UNEVENTFUL OUTCOME. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237201010392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E016

    Patients

    Seq Age Sex Outcome Treatment
    1