BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7705835 · Received July 20, 2018

    Report

    Report Number
    3004209178-2018-16266
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    July 5, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. HCP CALLED DUE TO HIGH IMPEDANCES. THE FOLLOWING CONTACTS OBSERVED THE FOLLOWING IMPEDANCE MEASUREMENTS: C0 1582 OHMS; C1 1087 OHMS; C2 1513 OHMS; C3 1122 OHMS; 01 >4000 OHMS; 02 >4000 OHMS; 03 4000 OHMS; 12 >4000 OHMS; 13 1513>4000 OHMS; 23 >4000 OHMS. AS A RESULT OF WHAT WAS REPORTED, THE CALL CENTER SUGGESTED RUNNING IMPEDANCES AGAIN AT A HIGHER AMPLITUDE IF MEDICALLY APPROPRIATE; IT CAN BE NOTED THAT THE PATIENT WAS PROGRAMMED AT 1- 3+. AT 2.0V AT 360 PULSE WIDTH (PW), THE FOLLOWING CONTACTS OBSERVED THE FOLLOWING IMPEDANCE MEASUREMENTS: C1 996 OHMS; C0 C2 AND C3 WERE IN THE 1000 RANGE; 01 1983 OHMS; 02 3782 OHMS; 03 2524 OHMS; 12 2123 OHMS; 13 1889 OHMS; 23 2472 OHMS. IT CAN BE NOTED THAT THE PATIENT WAS RECEIVING GOOD THERAPY; THE HCP DIDN'T REPORT ANY IMPEDANCE HISTORY. IT WAS SUGGESTED TO THE HCP TO TAKE NOTE OF IMPEDANCES IN CASE THEY CHANGE AS WELL AS DUE TO SOME OF THE ELECTRODE COMBINATIONS ARE ON THE HIGHER SIDE. TROUBLESHOOTING RESOLVED REPORTED ISSUE. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER (HCP) RESPONDED TO A LETTER. WHEN ASKED IF THE CAUSE OF THE HIGH IMPEDANCE ISSUE WAS DETERMINED, THE HCP SAID THE ISSUE WAS RESOLVED. THE PATIENT'S WEIGHT WAS NOT TAKEN AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547765 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR