BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7294441 · Received February 24, 2018

    Report

    Report Number
    3007566237-2018-00552
    Event Type
    Injury
    Date Received
    February 24, 2018
    Date of Event
    January 1, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE - : PRODUCT ID: 3889-28, LOT# V914059, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V926181, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR ISSUES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ALMOST KILLED HER AND SOMETHING WENT HORRIBLY WRONG. THE PATIENT REPORTED THAT SHE BENT OVER TO PUT ON SWEATPANTS AND SOMETHING WENT INTO HER SPINAL CORD. THE PATIENT FURTHER STATED THAT THE WIRES WENT ALL WRONG IN HER SPINAL CORD AND SHE WAS ON THE FLOOR FOR 4 DAYS WITHOUT HELP, BECAUSE IT ELECTROCUTED HER TO DEATH. IT WAS NOTED THAT THE PATIENT HAD AN EMERGENCY SURGERY AND THE INS WAS REPLACED DUE TO THE ISSUE. IN ADDITION, THE PATIENT SAID SHE HAS HAD 2 DEVICES FOR 6 YEARS BUT IT WAS REVIEWED THAT THERE WAS ONLY 1 DEVICE ON FILE. THE PATIENT STATED THAT SHE HAS ONE PROGRAMMER FOR THE INS THAT WAS REPLACED/IMPLANTED AND NEEDS TO ORDER ANOTHER PROGRAMMER FOR THE OTHER INS. THE PATIENT STATED THAT INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION THEN SAID THERE WAS A PROBLEM, WHICH WAS STATED ABOVE. THERE WERE NO FURTHER COMPLICATIONS OR ANTICIPATIONS REPORTED WITH THIS EVENT. THERE WAS A PROBLEM, WHICH WAS STATED ABOVE. THERE WERE NO FURTHER COMPLICATIONS OR ANTICIPATIONS REPORTED WITH THIS EVENT. REFER TO REGULATORY REPORT: (B)(4) REGARDING INFORMATION RELATED TO THE OTHER IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138202 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R