BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2120209 · Received June 6, 2011

    Report

    Report Number
    3007566237-2011-04032
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COPY OF THIS ARTICLE MAY BE OBTAINED AT WWW.INTERSCIENCE.WILEY.COM.

    Description of Event or Problem · 1

    LITERATURE: ROTH TM. SUBCAPSULAR RELOCATION FOR SACRAL NEUROMODULATION PULSE GENERATOR IMPLANT REVISION. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2010;13(2): 145-146. SUMMARY: THIS ARTICLE DISCUSSED A TECHNIQUE OF SUBCAPSULAR PLACEMENT OF A PULSE GENERATOR (IPG) IN CASES OF REVISION FOR IMPLANT SITE PAIN (GLUTEAL) IN FIVE PTS BETWEEN 2005-2008. FOR EACH PT, THE IPG AND ELECTRODE WERE CAREFULLY REMOVED AND THE FLOOR OF THE CAPSULE WAS INCISED. THE SYSTEM WAS PLACED BENEATH THE FLOOR OF THE ORIGINAL CAPSULE AND A LAYERED CLOSURE WAS PERFORMED. ALL DEVICES ORIGINALLY HAD BEEN PLACED 2 CM FROM THE SKIN SURFACE. ORIGINALLY, SEVEN PTS WERE EVALUATED AND TREATED, BUT TWO PTS DID NOT UNDERGO REVISION AND HAD THE DEVICE SYSTEMS EXPLANTED INSTEAD. REPORTABLE EVENTS: THREE PTS EXPERIENCED PAIN AT THE IPG SITE DUE TO WEIGHT LOSS. EACH PT EITHER UNDERWENT SURGICAL REVISION TO RELOCATE THE IPG OR UNDERWENT EXPLANT OF THE DEVICE SYSTEM DUE TO LOSS OF RESPONSE IN ADDITION TO THE PAIN. ALL PTS WHO UNDERWENT REVISION WERE PAIN-FREE AND HAD UNEVENTFUL F/U RANGING BETWEEN SIX MONTHS AND THREE YRS. ONE PT EXPERIENCED PAIN AT THE IPG SITE AFTER LOSING 60 POUNDS SUBSEQUENT TO IMPLANT, AND EITHER UNDERWENT SURGICAL REVISION TO RELOCATE THE IPG OR UNDERWENT EXPLANT OF THE DEVICE SYSTEM BECAUSE OF LOSS OF RESPONSE IN ADDITION TO THE PAIN. IF A REVISION WAS PERFORMED, THE PT WAS PAIN-FREE AND HAD UNEVENTFUL F/U RANGING BETWEEN SIX MONTHS AND THREE YRS. THREE PTS EXPERIENCED PAIN AT THE IPG SITE DUE TO ROTATIONAL MOVEMENT OF THE IPG, AND EACH PT EITHER UNDERWENT SURGICAL REVISION TO RELOCATE THE IPG OR UNDERWENT EXPLANT OF THE DEVICE SYSTEM BECAUSE OF THE LOSS OF RESPONSE IN ADDITION TO THE PAIN. ALL PTS WHO UNDERWENT REVISION WERE PAIN-FREE AND HAD UNEVENTFUL F/U RANGING BETWEEN SIX MONTHS AND THREE YRS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION: MODEL EXTENSION, LOT# UNK| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: