BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6578109 · Received May 19, 2017

    Report

    Report Number
    3007566237-2017-01941
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    December 29, 2016
    Report Date
    June 16, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURING REPRESENTATIVE (REP) REPORTED ON BEHALF OF A HEALTHCARE PROVIDER (HCP) IN A CLINICAL STUDY THAT THE PATIENT HAD A MOTOR VEHICLE ACCIDENT (MVA) AND DEVELOPED PAIN AT THE BATTERY SITE 2 DAYS POST-ACCIDENT. THE DEVICE WAS SHUT OFF AND THE PAIN RESOLVED. X-RAYS WERE TAKEN AND THE IMAGES SHOWED GOOD LEAD PLACEMENT. THE DEVICE WAS TURNED BACK ON AND REPROGRAMMED. THE PATIENT RESOLVED WITH REPROGRAMMING ON (B)(6) 2016. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. IT WAS NOTED THAT THE ISSUE WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN ACCIDENT AND THE BATTERY SITE HAD PAIN POST MOTOR VEHICLE ACCIDENT (MVA). THE DEVICE WAS TURNED OFF AND ON, REPROGRAMMED AND RESOLVED. NO PAIN PRIOR TO THE ACCIDENT. IT WAS REPORTED THAT THEY HAD TO ASSUME THE PAIN WAS CAUSED BY THE ACCIDENT SINCE THERE WAS NO WAY TO KNOW PRIOR TO MVA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359916 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR