BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6598557 · Received May 30, 2017

    Report

    Report Number
    3004209178-2017-11271
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    October 5, 2016
    Report Date
    July 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28 LOT# VA131FS, IMPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD. (B)(4). PERTAIN TO PRODUCT ID 3889-28, LOT# VA131FS, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR ISSUES. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS DOING A LEAD REVISION ON THE DAY OF THE REPORT DUE TO THE PATIENT¿S TOES THAT WON¿T UNCURL OR UNFLEX. SINCE IMPLANT, THE PATIENT¿S TOE CURLED, THE PATIENT HAD BEEN REPROGRAMMED 4 TIMES, AND THE PATIENT¿S 2ND AND 3RD TOES HAD BEEN DEFORMED SINCE IMPLANT. ANY COMMUNICATION WITH THE PATIENT PROGRAMMER OR CLINICIAN PROGRAMMER CAUSED THE PATIENT¿S FOOT TO JERK. IT WAS NOTED THE PATIENT HAD GOOD THERAPY EFFICACY. THE HCP WAS MOVING THE IMPLANT TO THE RIGHT SIDE (LEAD AND INS). IMPEDANCE MEASUREMENTS WERE TAKEN AND THE PATIENT¿S IMPEDANCES WERE 800-1123 OHMS. IT WAS NOTED THIS WAS A SUDDEN ONSET OF SYMPTOMS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378799 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention