BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5200601 · Received November 4, 2015

    Report

    Report Number
    3004209178-2015-22163
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    August 18, 2015
    Report Date
    February 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 309328, LOT# 0208836049, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) FOR A CLINICAL STUDY, VIA A MANUFACTURER REPRESENTATIVE, REPORTED THE PATIENT HAD A RETURN OF POLLAKIURIA. IT WAS UNKNOWN WHAT LED TO THE EVENT. NO DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED. THE PATIENT'S ELECTRODE WAS CHANGED AND THE NEUROSTIMULATOR WAS REPROGRAMMED ON (B)(6) 2015, AND THE PATIENT WAS HOSPITALIZED FOR A DAY. THE EVENT RESOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS SERIOUS AND RELATED TO THE NEUROSTIMULATOR. RELEVANT MEDICAL HISTORY INCLUDES IDIOPATHIC FUNCTIONAL URINARY INCONTINENCE SINCE 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) FOR A CLINICAL STUDY, VIA A MANUFACTURER REPRESENTATIVE, REPORTED THE PATIENT'S STIMULATOR WAS ALSO CHANGED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURER REPRESENTATIVE, REPORTED THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2015, TO CHANGE THE ELECTRODE AND THE STIMULATOR WAS EXPLANTED ON (B)(6). A NEW STIMULATOR WAS IMPLANTED ON (B)(6) 2015. THE INVESTIGATOR ASSESSED THE EVENT AS NOT SERIOUS AND LINKED TO THE STIMULATOR AND ELECTRODE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) FOR A CLINICAL STUDY, VIA A MANUFACTURER REPRESENTATIVE, REPORTED THERE WAS A TECHNICAL BREAKDOWN OF THE DEVICE AFTER PASSING A SECURITY BARRIER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE REPORTING THAT THERE WAS SUSPICION OF LEAD MIGRATION. IT WAS DECIDED CONSERVATIVELY TO CHANGE THE LEAD AT THE TIME OF STIMULATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732045 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| R