BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2113833 · Received May 17, 2011

    Report

    Report Number
    3007566237-2011-03593
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 1, 2005
    Report Date
    July 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: KESSLER T, MADERSBACHER H, KISS G, "BILATERAL MIGRATION OF SACRAL NEUROMODULATION TINED LEADS IN A THIN PATIENT" THE JOURNAL OF UROLOGY 2005; VOL. 173, 153-154. SUMMARY: THIS ARTICLE DESCRIBES A CASE STUDY OF A (B)(6) FEMALE PATIENT WITH A BODY MAX INDEX OF (B)(6) SUFFERING FROM REFRACTORY OVERACTIVE BLADDER SYNDROME, WHO WAS IMPLANTED WITH AN IPG AND TWO TINED LEADS. EVENT: DURING THE TRIAL PERIOD, X-RAYS TAKEN ONE DAY AFTER IMPLANT OF THE TINED LEADS SHOWED DORSAL MIGRATION OF BOTH LEADS. INSOFAR AS THE DISTAL PART OF THE LEAD REMAINED IN THE TARGET AREA, NO SURGICAL REVISION WAS PERFORMED. GOOD CLINICAL RESULTS WERE ACHIEVED BY STIMULATION OF THE LEFT DISTAL ELECTRODES FOR THE NEXT 2 WEEKS. ONE DAY PRIOR TO IMPLANT OF THE IPG, AN X-RAY REVEALED VENTRAL MIGRATION OF THE LEFT LEAD. THE IPG WAS IMPLANTED AND CONNECTED TO THE LEFT LEAD. THE RIGHT LEAD WAS NOT CONNECTED. THE POSITIVE CLINICAL RESULTS ACHIEVED DURING TRIAL WERE MAINTAINED. THE POST-OPERATIVE COURSE WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR EXPLANTED:| LEAD: MODEL 3093, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# UNKNOWN