BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4152025 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18496
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-33, LOT# V240730, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REGARDING THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS), THE PATIENT HAD "THE LAST STIMULATOR IN SINCE 2010, BUT THE DOCTOR HAD TO TAKE IT OUT BECAUSE ANOTHER DOCTOR HIT 7 NERVES". IT WAS NOTED THE DOCTOR "DAMAGED THE WHOLE INTERSTIM WHEN HE HIT 7 NERVES AND 2 DISCS IN MY BACK, IT WAS THIS PAST (B)(6) 2014". IT WAS ALSO NOTED THE DEVICE WAS REPLACED ON (B)(6) 2014 DUE TO NORMAL BATTERY DEPLETION. THE PATIENT INQUIRED ABOUT BATTERY LONGEVITY - THE PATIENT STATED HER DOCTOR TOLD HER ABOUT 4 YEARS. THE PATIENT'S REPRESENTATIVE RECOMMENDED PATIENT NOT USE HIGH SETTINGS TO HELP HER BATTERY LAST LONGER. IT WAS ALSO NOTED THAT THE PATIENT HAD TO HAVE A CATHETER SINCE 2010. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633037 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention