BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1015573 · Received March 19, 2008

    Report

    Report Number
    2182207-2008-01383
    Event Type
    Injury
    Date Received
    March 19, 2008
    Report Date
    February 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: CHUNG ET AL. "EFFICACY AND SAFETY OF SACRAL NEUROMODULATION (INTERSTIM) FOR THE TREATMENT OF REFRACTORY OVERACTIVE BLADDER SYMPTOMS AND CHRONIC PELVIC PAIN." KOREAN J UROL 2007; 48(7):701-705.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CHUNG ET AL. "EFFICACY AND SAFETY OF SACRAL NEUROMODULATION (INTERSTIM) FOR THE TREATMENT OF REFRACTORY OVERACTIVE BLADDER SYMPTOMS AND CHRONIC PELVIC PAIN." KOREAN J UROL 2007; 48(7):701-705. THE AUTHORS EVALUATED THE EFFICACY AND SAFETY TO SACRAL NEUROMODULATION FOR TREATING PATIENTS SUFFERING WITH AN OVERACTIVE BLADDER (OAB) OR CHRONIC PELVIC PAIN (CPP) THAT WAS REFRACTORY TO CONSERVATIVE THERAPIES. A TOTAL OF 30 PTS UNDERWENT TESTING WITH SACRAL NERVE MODULATION VIA EITHER A TRADITIONAL PERCUTANEOUS APPROACH OR A STAGED PROCEDURE TO PREDICT THE EFFICACY OF THIS TREATMENT FOR REFRACTORY OAB AND/OR CPP. SEVENTEEN PATIENTS UNDERWENT A PROCEDURE TO IMPLANT A PERMANENT SACRAL NERVE STIMULATION. AVERAGE FOLLOW-UP WAS 21.6 MONTHS. REPORTABLE EVENT: THE COMPLICATIONS REPORTED RELATED TO THE SURGICAL OPERATIONS INCLUDED TWO CASES OF LEG NUMBNESS, THE PTS SIMULTANEOUSLY UNDERWENT THE CONSERVATIVE TREATMENT SUCH AS THE ADMINISTRATION OF ANALGESICS TOGETHER WITH SACRAL NEUROMODULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK EZW MEDTRONIC NEUROMODULATION LEAD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PROGRAMMER MODEL: UNK| IMPLANTABLE PULSE GENERATOR: MODEL 3023