BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8845070 · Received July 31, 2019

    Report

    Report Number
    3004209178-2019-14643
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    April 1, 2019
    Report Date
    September 26, 2019
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER: PATIENT REPORTS THEY CHANGE THE BATTERIES IN THEIR PROGRAMMER EVERY 1 OR 2 MONTHS. WHEN ASKED WHAT WAS THE CAUSE OF THE RETURN OF SYMPTOMS FOLLOWING THE FALL DETERMINED THE PATIENT RESPONDED THAT THEY THINK THEIR BODY GOT USED TO THE OLD SETTING, NOW THEY¿VE INCREASED THE SETTING WHICH HAS HELPED THE SYMPTOMS, AND THE SYMPTOMS WERE MOSTLY RESOLVED. PATIENT WEIGHT WAS ABOUT 200 POUNDS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Additional Manufacturer Narrative · 1

    DATE IS APPROXIMATE. 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 WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT REPORTED THEY WERE HAVING A HARD TIME GETTING IT TO WORK. THEY WERE WETTING THE BED. THEY HAD NO CONTROL OVER THEIR BLADDER AT ALL, THE NOTED IT HAD STARTED ABOUT 3 MONTHS PRIOR AND WAS GETTING WORSE. THEY ALSO REPORTED THEY WERE HAVING AN OCCASIONAL BOWEL ACCIDENT, WHICH ALSO STARTED ABOUT 3 MONTHS PRIOR. THEY SAID THEY HAD TRIED WORKING WITH THE SYSTEM ALL WEEK AND THEY WERE PUTTING NEW BATTERIES IN CONTINUALLY. THEY SAID THEY WERE WETTING THE BED AND DURING THE DAY TIME TOO. THEY WERE ON PROGRAM 1 AT 1.5 VOLTS AND HAD INCREASED TO 3.3 VOLTS. THEY SAID THEY COULD USUALLY FEEL STIMULATION, BUT DIDN'T FEEL IT AT THE TIME OF THE REPORT AND IT WOULDN'T LET THEM INCREASE. THEY WERE ABLE TO SYNC ON THE CALL AND THE PATIENT PROGRAMMER SHOWED STIMULATION WAS ON. THEY WERE ABLE TO INCREASE STIMULATION ON PROGRAM 1 TO 4.6 VOLTS WITH NO ISSUE. IT WAS NOTED THEY WERE FEELING STIMULATION IN THE CORRECT AREA. I T WAS NOTED THAT THE PATIENT REPORTED THERE WAS A FALL RELATED TO THE REPORTED ISSUE, THEY STATED THEY HAD SOME FALLS, THEY DIDN'T FEEL LIKE THEY HAD GOOD TRACTION, LIKE THEY WERE NOT STURDY. THEY REPORTED THIS WAS A GRADUAL CHANGE AND THEY WERE TOLD TO MONITOR SYMPTOMS TO SEE IF THEY IMPROVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642702 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR