BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7143448 · Received December 22, 2017

    Report

    Report Number
    3004209178-2017-26590
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Report Date
    December 22, 2017
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. PATIENT STATES SYMPTOM IMPROVEMENT IS GREAT AND THE DEVICE HAS BEEN LIFE CHANGING. THEY FURTHER ADDED THAT ON AN INFREQUENT BASIS, SOMETIMES ONCE A MONTH BUT AT OTHER TIMES ONCE EVERY OTHER MONTH, THE PATIENT WILL FEEL WARMTH AROUND THE INS IMPLANT SITE ON THEIR SKIN. THEY ALSO HAVE BEEN HAVING ITCHING THAT WILL LAST FOR A DAY OR TWO. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS ARE KNOWN THAT CONTRIBUTE TO THESE SYMPTOMS. THE INFORMATION WAS PRESENTED DURING A ROUTINE PRP BATTERY CHECK OF THE DEVICE. IMPEDANCES ARE NORMAL WITH ALL VALUES WITHIN ACCEPTABLE RANGES AND BATTERY LIFE SHOWS 28 TO 50 MONTHS REMAINING. AFTER THE REP WAS INFORMED OF THE SITUATION, THEY RELAYED THE INFORMATION TO THE MANAGING HEALTHCARE PROVIDER'S (HCP) PHYSICIAN ASSISTANT. THE PHYSICIAN'S ASSISTANT PERFORMED AN EXAM ON THE IMPLANT SITE AND THERE WERE NO SIGNS OF INFECTION OR ANYTHING ABNORMAL. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND NO SURGICAL INTERVENTION WILL OCCUR OR IS SCHEDULED TO OCCUR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923136 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR