BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2402276 · Received January 6, 2012

    Report

    Report Number
    3007566237-2012-00048
    Event Type
    Injury
    Date Received
    January 6, 2012
    Report Date
    December 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INS MODEL UNK, SERIAL# UNK, IMPLANTED: UNK, EXPLANTED: UNK.

    Description of Event or Problem · 1

    LITERATURE: CHAABANE, W., GUILLOTREAU, J., CASTEL-LACANAL, E., ABU-ANZ, S., DE BOISSEZON, X., MALAVAUD, B., MARQUE, P., SARRAMON, J. P., RISCHMANN, P., GAME, G. SACRAL NEUROMODULATION FOR TREATING NEUROGENIC BLADDER DYSFUNCTION: CLINICAL AND URODYNAMIC STUDY. NEUROUROLOGY AND URODYNAMICS. 2011;30(4):547-550. DOI: 10.1002/NAU. SUMMARY: THIS RETROSPECTIVE STUDY ASSESSED THE RESULTS OF SACRAL NEUROMODULATION IN NEUROGENIC BLADDER DYSFUNCTION. SIXTY-TWO PATIENTS WITH NEUROGENIC LOWER URINARY TRACT DYSFUNCTION INCLUDING OVERACTIVE BLADDER SYNDROME, CHRONIC URINARY RETENTION AND RETENTION ASSOCIATED WITH DETRUSOR OVERACTIVITY UNDERWENT A PERCUTANEOUS NERVE EVALUATION (PNE) OR TWO-STAGE TECHNIQUE BETWEEN 1998 AND 2008. THIRTY-SEVEN PATIENTS RECEIVED AN IMPLANTABLE PULSE GENERATOR (IPG). IMPLANTED PATIENTS WERE SEEN AT 1 MONTH, 6 MONTHS AND THEN EVERY YEAR WITH A MEAN FOLLOW-UP OF 4.3 YEARS. THE AUTHORS CONCLUDED THAT SACRAL NEUROMODULATION SEEMED TO CONSTITUTE A SERIOUS THERAPEUTIC OPTION FOR PATIENTS WITH NEUROGENIC LOWER URINARY TRACT DYSFUNCTION BUT THE RESULTS DEPENDED ON THE TYPE OF UNDERLYING DISEASE AND WHETHER IT MIGHT PROGRESS OR NOT. REPORTED EVENTS: THERE WERE FOUR CASES OF INFECTION AT THE LEVEL OF THE LEAD DURING THE TEST PERIOD. THERE WAS ONE CASE OF LEAD RUPTURE DURING THE TEST PERIOD. THERE WERE TWO CASES OF REVISION DUE TO LEAD MIGRATION. THERE TWO CASES OF REVISION DUE OPERATION SITE INFECTION. THERE WERE TWO CASES OF REVISION DUE TO NEUROSTIMULATOR FAILURE FOLLOWING TRAUMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL UNK, LOT # UNK