BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4929666 · Received July 21, 2015

    Report

    Report Number
    3004209178-2015-13800
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    January 1, 2013
    Report Date
    February 10, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V881399, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V881399, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WITH TWO LEAD WIRES, THEY FRACTURED/ BROKE. THIS OCCURRED 2 YEARS AGO. THE WHOLE SYSTEM WAS REPLACED BECAUSE THE BATTERY WAS AT 50%. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470887 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention