BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 9795058 · Received March 5, 2020

    Report

    Report Number
    3004209178-2020-04763
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    February 25, 2020
    Report Date
    March 30, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT#: V840309, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 05-OCT-2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP).THE DEVICE HAD NOT BEEN REPLACED ON (B)(6) BUT WAS SCHEDULED FOR REPLACEMENT WHICH WAS DONE TODAY (B)(6) 2020. THE DEVICE WAS DISCARDED AT THE DOCTORS REQUEST AND WILL NOT BE RETURNED TO MEDTRONIC.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS AGO, THE PATIENT WAS IN THE SHOWERS AND FELT A SUDDEN SHOCK THAT LAST ABOUT 20 SECONDS THEN IT SHUTS OFF AND HAS REMAINED OFF SINCE. THE PATIENT HAD AN X-RAY TO TROUBLESHOOT THE ISSUE. A REVISION AND REPLACEMENT WAS PLANNED TO RESOLVE THE ISSUE. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258813 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention