BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3230162 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11859
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 24, 2013
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-33, LOT# V049137, IMPLANTED: 2007-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE REPORTER INDICATED THAT THE PATIENT ¿WAS ZAPPED GOOD¿ WHEN SHE WALKED THROUGH A SECURITY GATE AT WALMART. THE DEVICE WAS ON DURING THAT TIME. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE HEALTH CARE PROFESSIONAL OR MANUFACTURER'S RE PRESENTATIVE AND HER CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2013 AND HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. PER MANUFACTURER¿S DEVICE REGISTRY, THE PATIENT¿S SYSTEM WAS REPLACED ON THE DAY OF SURGERY NOTED. REFER TO MANUFACTURER¿S REPORT NUMBER 3004209178-2013-11678 FOR ADDITIONAL PATIENT AND DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328845 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention