BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7654713 · Received July 2, 2018

    Report

    Report Number
    3004209178-2018-14749
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 8, 2018
    Report Date
    October 5, 2018
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    PATIENT RESPONDED TO A LETTER. WHEN ASKED TO CLARIFY THE STIMULATOR NOT WORKING/FEAR OF A DISCONNECT, THE PATIENT SAID THE TEMPORARY STIMULATOR WORKED GREAT, BUT THE IMPLANTABLE NEUROSTIMULATOR (INS) IS NOT. THE PATIENT SAID THEY HAVE A NEUROGENIC BLADDER AND HAVE SPHINCTER DYSSYNERGIA MUSCLE THAT ISN'T WORKING (NOT RELATED TO DEVICE/THERAPY). THEY WANT TO HAVE ANOTHER SURGERY TO HELP THEIR NEUROGENIC BLADDER AND SPHINCTER DYSSYNERGIA MUSCLE PROBLEMS. WHEN ASKED WHAT WERE THE CIRCUMSTANCES THAT LED TO THE STIMULATOR NOT WORKING/FEAR OF A DISCONNECT, THE PATIENT SAID THEIR DEVICE WORKS FINE, BUT IT IS NOT A RIGHT FIT FOR THEM. THEY USE A "2.7 + 3.0" STIMULATOR AND IT JUST DOESN'T MAKE THEM HAVE AN URGE TO GO; IT ISN'T DOING THE JOB FOR THEM. THEY WANT OTHER SURGERY OPTIONS (FOR THE NEUROGENIC BLADDER AND HAVE SPHINCTER DYSSYNERGIA MUSCLE ISSUE). WHEN ASKED WHAT STEPS WERE TAKEN TO RESOLVE THE STIMULATOR NOT WORKING/FEAR OF A DISCONNECT, THE PATIENT SAID THERE HAVEN'T BEEN ANY ASIDE FROM CHANGING THEIR SETTINGS. THE PATIENT ALSO SAID THEY WERE SELF-CATHETERIZING FOUR TIMES A DAY AND THEY DON'T WANT TO CONTINUE DOING THAT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    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.

    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 RECEIVED. PATIENT REPORTED HAVING THE IMPLANT AND STATED THAT SHE DOESN'T WANT TO TURN IT UP TOO HIGH TO THE POINT WHERE IT HURTS AND THAT IT ISN'T WORKING AS WELL AS THE EVALUATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND A HEALTH CARE PROFESSIONAL REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT PATIENT'S STIMULATOR WAS NOT WORKING AND THE DOCTOR FEARED THERE WAS A DISCONNECT AND THAT THEY WERE DOING AN MRI OF THE BRAIN. PATIENT WAS STILL CATHETERIZING 4 TIMES A DAY, THE DEVICE HAD NOT HELPED, AND THEY HAD THE ISSUE SINCE (B)(6) 2016. IT WAS NOTED THAT THEY WERE TAKING AN MRI OF THE BRAIN TO MAKE SURE THERE WAS NOTHING GOING ON UP THERE. NO FURTHER COMPLICATIONS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498824 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR