BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5831414 · Received July 28, 2016

    Report

    Report Number
    3004209178-2016-15142
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    February 1, 2016
    Report Date
    September 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28, LOT# V195597, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-28, LOT# V161901, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    SEE MFR. REPORT #3004209178-2016-15141 REGARDING ANOTHER DEVICE SYSTEM INVOLVED IN THE EVENT. CONCOMITANT PRODUCT(S): PRODUCT ID: 3093-28, LOT# V195597, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3093-28, LOT# V161901, IMPLANTED: (B)(6) 2009, 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

    ADDITIONAL INFORMATION FROM A PATIENT REPORTED THE LEADS WERE INTERFERING WITH EACH OTHER BECAUSE ONE DOCTOR PUT BOTH DEVICES ON ONE SIDE OF THEIR BODY. THE PATIENT NEW DOCTOR SAID THIS WAS A PROBLEM. THE PATIENT STATED THAT NEITHER DEVICE WOULD GIVE THEM RELIEF. THE PATIENT COULD ONLY HAVE ONE ON AT A TIME WHICH IS NOT ENOUGH TO PROVIDE RELIEF TO THE PATIENT, THE PATIENT SAID THEY NEED BOTH WORKING. THE PATIENT REPORTED THEY HAD A SURGERY WITH THE NEW DOCTOR WHO SWITCHED ONE DEVICE TO THE OTHER SIDE OF THEIR BODY SO THAT WOULD WORK. THE PATIENT STATED THE DEVICE ON THE RIGHT SIDE IS NO LONGER WORKING. THE DEVICE ON THE RIGHT SIDE IS NOT DETECTING ANY LEADS. THE PATIENT ADDED IT LOOKS LIKE SURGERY AGAIN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION IN (B)(6) 2016 WHEN THE HEALTHCARE PROVIDER MOVED ONE OF HER LEADS TO THE RIGHT SIDE. IT WAS DETERMINED BEFOREHAND THEY WERE INTERFERING WITH EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481831 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention