BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7233491 · Received February 1, 2018

    Report

    Report Number
    3004209178-2018-01798
    Event Type
    Injury
    Date Received
    February 1, 2018
    Report Date
    February 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V010296, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. MANUFACTURER REPRESENTATIVE REPORTED THE BATTERY WAS REPLACED DUE TO BATTERY DEPLETION. DISCOMFORT WAS FIRST REPORTED FOLLOWING THE BATTERY REPLACEMENT AND THE STIMULATION WAS TURNED ON. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF EFFICACY AND PAIN IN THEIR LEG FROM THE STIMULATION. THERE WERE NO REPORTED CONTRIBUTING FACTORS RELATED TO THE EVENT. AN IMPEDANCE TEST HAD BEEN RUN AND THE TEST DID NOT DEMONSTRATE ANY ISSUES WITH THE SYSTEM. THE DEVICE HAD ALSO BEEN PROGRAMMED BY OFFICE STAFF. AN INS REPLACEMENT HAD BEEN DONE ON (B)(6) 2017 AND THE PATIENT REPORTED A LACK OF EFFICACY AND DISCOMFORT IN THEIR LEG FROM THE STIMULATION. ON (B)(6) 2018 THE EXISTING LEAD WAS REPLACED. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED AND THE PATIENT STATUS WAS ALIVE-NO INJURY AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. MANUFACTURER REPRESENTATIVE REPORTED THAT AT THE ORIGINAL REPLACEMENT PROCEDURE, IT WAS ASSUMED THAT THE DEVICE HAD REACHED ITS NATURAL END OF LIFE (EOL). NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78142 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention