BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3010006 · Received March 18, 2013

    Report

    Report Number
    3004209178-2013-03894
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 27, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# VA03DT9, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3093-28, LOT# VA03DT9, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SHE ENTERED A SECURITY SYSTEM. IT WAS STATED THAT THE SHOCK WAS DESCRIBED AS "A CHANGE IN INTENSITY THAT THE PATIENT FELT IN HER VAGINA." ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS ¿LAUGHING¿ WHEN THEY WERE TELLING THEIR HEALTHCARE PROVIDER ABOUT THE EVENT. IT WAS STATED THE PATIENT HAD NO ADVERSE EVENTS. IT WAS ADDED THAT THE PATIENT ¿WOULD GO QUICKLY THROUGH THE GATE NEXT TIME, OR TURN THE DEVICE OFF.¿ NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112575 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1