BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6452405 · Received April 2, 2017

    Report

    Report Number
    3004209178-2017-06827
    Event Type
    Malfunction
    Date Received
    April 2, 2017
    Date of Event
    February 24, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 FROM THE PATIENT. THE STEPS TAKEN TO RESOLVE THE ELECTRICAL CHARGES FELT IN THE BUTTOCKS WAS THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF. THE DOCTOR WILL EVALUATE THE PATIENT ON (B)(6) 2017. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY WERE 5¿9¿ AND WEIGHED (B)(6) POUNDS AT THE TIME OF THE EVENT. IN ORDER TO RESOLVE THE ELECTRICAL CHANGES FELT IN THE BUTTOCKS THE DEVICE HAD BEEN TURNED OFF, BUT IT STILL SHOCKED THEM TWICE WHILE BEING OFF. AN APPOINTMENT WAS SCHEDULED WITH THE SPECIALIST FOR (B)(6). NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR WHO REPORTED THAT THE PATIENT'S IMPLANT "SEEMS TO BE FRITZEN." THE CALLER STATED THAT THE ISSUES WAS "NOT THE STIMULATOR BUT ACTUALLY THE BATTERY PACK." ACCORDING TO THE CALLER THE PATIENT EXPERIENCED DISCHARGES OR ELECTRICAL CHARGES ESPECIALLY WHEN REALLY COLD. THE PATIENT DESCRIBED THE SENSATIONS AS A "STARBURST IN MY BUM." THE SENSATIONS REPORTED WERE MOMENTARY AND GO AWAY WITHOUT INTERVENTION, BUT THE INCIDENCES WERE INCREASING. THERE WERE NO TRAUMA OR FALLS THAT WERE REPORTED RELATED TO THIS ISSUE, HOWEVER IT WAS REPORTED THAT WHEN THE PATIENT WAS SLIDING INTO THE BACK SEAT OF A VEHICLE THE SEATBELT WAS UP AND THEY HIT IT PRETTY HARD. THIS WAS DESCRIBED AS "AN OWW." THERE WERE NO RECENT MEDICAL TESTS OR EXPOSURE TO POTENTIAL SOURCES OF ELECTROMAGNETIC INTERFERENCE. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234111 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR