BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3813703 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09061
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    October 20, 2011
    Report Date
    November 1, 2016
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3093-28, LOT# V811041, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3093-28, LOT# V256969, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V811041, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT # V256969, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT ONE TIME THE PATIENT WAS SHOCKED SO BAD THEY THOUGHT THEY WOULD DIE AND HAD CONVULSIONS AND THEIR EYES ROLLED BACK. THE SHOCKING TOOK PLACE AFTER THE WIRES WERE FIXED, AFTER (B)(6) 2011.

    Description of Event or Problem · 1

    A PATIENT REPORTED HER FIRST DEVICE WASN¿T WORKING. THE PATIENT STATED IT WORKED OK AT FIRST THEN STOPPED, THE PATIENT STATED THAT IT ¿JUST WASN¿T WORKING¿. THE PATIENT STATED IT CAUSED HER PAIN AND TENDERNESS. THE PATIENT NOTED THAT SHE FELL ONCE AND THE DEVICE SHIFTED, THE PATIENT STATED IT WAS SLIPPING. THE PATIENT ALSO NOTED SHE WAS GETTING SHOCKED. THE PATIENT DID NOT KNOW WHEN THE DEVICE STOPPED WORKING. THE PATIENT STARTED THE PAIN, TENDERNESS, AND SHOCKING BEGAN ON (B)(6) 2009. THE PATIENT DID NOT KNOW THE DATE THEY FELL AND THE DEVICE SHIFTED. THE PATIENT IS IMPLANTED FOR GASTROINTESTINAL/PELVIC FLOOR. INFORMATION OMITTED ABOUT SECOND DEVICE NOT WORKING, RETENTION, BROKEN LEAD AS IT IS COVERED IN (B)(4). INFORMATION OMITTED ABOUT TRIAL INFECTIONS AS IT IS COVERED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291067 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other