BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3022242 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04272
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 093-33, LOT# V758541, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS MAKING IT VERY DIFFICULT TO WALK. IT WAS FURTHER REPORTED THAT THE PATIENT HAD TURNED THE DEVICE OFF ABOUT A MONTH PRIOR TO THE REPORT BUT SHE COULD STILL FEEL IT "PULSATING" FROM HER BUTTOCKS TO HER VAGINA. IT WAS NOTED THAT "IT WAS WORKING ON THE PATIENTS NERVOUS SYSTEM, AND AT TIMES IT HURT HER LEGS SO BAD SHE COULD NOT EVEN WALK." THE PATIENT REPORTEDLY HAD THIS PAIN SINCE SHE HAD THE SURGERY OR POSSIBLE A "COUPLE" MONTHS AFTER THE SURGERY. IT WAS ALSO NOTED THAT THE PATIENT FEELS TINGLING IN HER LEGS. THE PATIENT REPORTEDLY COULD NOT TAKE THE PAIN ANY LONGER AND CALLED THE E.R. THE PATIENT REPEATEDLY STATED THAT IT WAS "WORKING ON HER NERVES." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED (B)(6) 2013 THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. APPOINTMENT (B)(6) 2013. THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. THE PATIENT WAS HAVING BAD LEG PAIN, RIGHT LEG.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER REPORTEDLY WANTED TO DO AN MRI BECAUSE, THEY THOUGHT THE DEVICE WAS WORKING ON THE NERVES OF THE PATIENT'S LEGS. A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124663 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability