BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2247845 · Received September 6, 2011

    Report

    Report Number
    3007566237-2011-07455
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    October 6, 2010
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: SIDDIQUI NY, AMUNDSEN CL, COREY/EG, WU JM. LEAD MIGRATION AFTER SACRAL NEUROMODULATION: SURGICAL REVISION IN FASCIAL VERSUS TINED ANCHORING SYSTEMS. INT UROGYNECOL J PELVIC FLOOR DYSFUNCT 2011; 22(4):419-423. DOI 10.1007/S00192-010-1285-Z. SUMMARY: THE AUTHORS COMPARED THE RISK OF SURGICAL REVISION FOR LOSS OF EFFICACY AFTER LEAD MIGRATION IN THOSE UNDERGOING SACRAL NEUROSTIMULATION VIA FASCIAL VERSUS TINED ANCHORING SYSTEMS. A RETROSPECTIVE COHORT STUDY OF PTS RECEIVING SACRAL NEUROMODULATION OVER 7 YEARS (FROM (B)(6) 2000 TO (B)(6) 2006) WERE REVIEWED ACCOMPANIED BY RADIOGRAPHIC EVIDENCE. OF 112 PTS, 28 (25%) UNDERWENT FASCIAL ANCHORING, AND 84 (75%) RECEIVED TINED LEADS. WITHIN 2 YEARS OF IMPLANTATION, LEAD MIGRATION OCCURRED IN 26% OF FASCIAL AND 10% OF TINED ANCHORING SYSTEMS. IN A LOGISTIC REGRESSION MODEL WHICH CONTROLLED FOR AGE, RACE, BODY MASS INDEX, AND TOBACCO USE, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN FASCIAL ANCHORS AND TINED LEADS. REPORTABLE EVENT: THE AUTHORS REPORT THAT ONE FEMALE PT UNDERWENT LEAD REVISION OF A TINED LEAD 3 MONTHS AFTER IMPLANTATION AND HAD ANOTHER IMMEDIATE MIGRATION WITH A TINED LEAD, DIAGNOSED WITHIN 1 DAY. SHE UNDERWENT LEAD REVISION WITH A FASCIAL ANCHOR, SUSTAINED ANOTHER CLINICALLY EVIDENT MIGRATION, AND HAD THE SYSTEM EXPLANTED. IN A LOGISTIC REGRESSION MODEL WHICH CONTROLLED FOR AGE, RACE, BODY MASS INDEX, AND TOBACCO USE, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN FASCIAL ANCHORS AND TINED LEADS.

    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 58 YR Required Intervention EXPLANTED:| LEAD: MODEL LEAD URO, LOT # UNK| IMPLANTED: