BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6105359 · Received November 16, 2016

    Report

    Report Number
    3004209178-2016-24104
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    February 1, 2016
    Report Date
    November 16, 2016
    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
    VA, 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# VA0PET3, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE TURNED STIMULATION OFF DUE TO PAIN. THE PATIENT STATED SHE DOESN'T KNOW IF THE PAIN WAS RELATED TO THE STIMULATOR OR NOT. A CT SCAN WAS RECENTLY TAKEN AND HER HEALTH CARE PROVIDER (HCP) THOUGHT FLUID MIGHT BE BEHIND THE DEVICE. THE PATIENTS INDICATORS WERE FOR BOWEL DYSFUNCTION/SACRAL NERVE STIM /SACRAL NERVE STIM/ GASTROINTESTINAL/ PELVIC FLOOR. ADDITIONAL INFORMATION FROM THE PATIENT REPORTED THEY HAVE HAD PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE SINCE 9 MONTHS - 1 YEAR AGO. THE PAIN WAS GETTING WORSE. THEY REPORTED TWO FALLS THAT OCCURRED ABOUT 6 MONTHS PRIOR TO THE REPORT AND THEY DON'T REMEMBER HITTING THE DEVICE. THEN, AGAIN 60 DAYS PRIOR TO THE REPORT. WHEN THEY BEND OVER OR HAVE A BOWEL MOVEMENT THEY FEEL A SHOCKING SENSATION, BUT DID NOT KNOW WHEN IT OCCURRED. THEY WENT TO THE HEALTHCARE PROVIDERS (HCP) OFFICE AND THEY TOLD THE PATIENT THAT ONE OF THEIR LEAD WIRES WAS BROKEN. ON THE DAY OF THE REPORT, THE PATIENT STATED THAT STIMULATION WAS JUMPING ALL OVER THE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758991 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR