BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7797169 · Received August 20, 2018

    Report

    Report Number
    3004209178-2018-18618
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    April 14, 2016
    Report Date
    October 19, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION PRODUCT ID 3889-28 LOT# VA04A8N IMPLANTED: (B)(6)2013 EXPLANTED: (B)(6)2016 PRODUCT TYPE LEAD MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2016, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRDOUCTS: PRODUCT ID: 3889-28, LOT# VA04A8N, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IN A CLINICAL STUDY WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR ISSUES. IT WAS REPORTED THAT AN X-RAY SHOWED THAT THE LEAD HAD MOVED OUT OF THE OPTIMAL POSITION; THE DEVICE DIAGNOSIS WAS A LEAD MIGRATION/DISLODGEMENT. THERE WAS NO EVIDENCE OF KINKING OR DISCONTINUITY OF THE METALLIC LEAD; THE TIP OF THE LEAD WAS PROJECTED ANTERIOR TO THE LEFT SIDE OF THE 3RD SACRAL PIECE. IT WAS NOTED THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. INTERVENTIONS TAKEN INCLUDED EXPLANTING/REPLACING THE ENTIRE SYSTEM. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2016. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    NO NEW INFORMATION WAS REPORTED (THE PATIENT'S WEIGHT WAS REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640583 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention