BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6511412 · Received April 21, 2017

    Report

    Report Number
    3004209178-2017-08794
    Event Type
    Injury
    Date Received
    April 21, 2017
    Report Date
    May 18, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-33, LOT# V063616, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2017, PRODUCT TYPE LEAD. 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 THE OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-33, LOT# V063616, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. 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

    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 URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR WHO REPORTED THAT THE PATIENT HAD THEIR LEAD REPLACED ON THE FRIDAY PRIOR TO THE CALL. THE PATIENT INDICATED THAT THEY HAD BEEN HAVING PROBLEMS WITH THEIR LEAD. THE REASON FOR THE LEAD REPLACEMENT IS UNKNOWN. NO PATIENT SYMPTOMS WERE REPORTED. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER (CON). IT WAS REPORTED THAT THE PATIENT HAD A FALL ON THEIR BUTT AND THOUGHT THAT WAS WHEN THE LEAD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294027 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention