BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3191324 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10928
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 5, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28 LOT# VA02R42, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    FURTHER INFORMATION RECEIVED REPORTED THE PATIENT WAS SEEN BY THEIR HEALTH CARE PROVIDER ON 2013 (B)(6). IT WAS REPORTED THE PATIENT THEN ¿FELT THE ¿SHOCKING¿ PAINS WERE RELATED TO HER BULGING DISC AND NOT ANY PROBLEM WITH THE INS.¿ IT WAS ALSO REPORTED, THE PATIENT HAD BEEN DOING WELL WITH ¿NOCTURIA 1-2X AND DAY TIME VOIDS Q2 HOURS.¿ IT WAS NOTED THERE WERE NO FURTHER ¿SHOCKING¿ PAINS. IT WAS NOTED THAT NO IMPEDANCE PROBLEM WAS DETECTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS FIRST IMPLANTED SHE HAD A ¿SHOCKING PAIN¿. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291204 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1