BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4824774 · Received June 8, 2015

    Report

    Report Number
    3004209178-2015-10446
    Event Type
    Injury
    Date Received
    June 8, 2015
    Report Date
    May 19, 2015
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE INS S/N: (B)(4) FOUND THAT THE SETSCREW WAS BACKED OUT TOO FAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT HER DEVICE POCKET AND LESS THAN 50% SYMPTOM RELIEF. IT WAS ALSO REPORTED THAT THE PATIENT HAD SOME FALLS, BUT THESE WERE NOT NOTED TO BE RELATED TO HER DEVICE. THE PATIENT WAS EVALUATED BY HER PHYSICIAN AND HE DETERMINED THAT THE PATIENT¿S BATTERY HAD DEPLETED PREMATURELY. THIS OCCURRED DURING NORMAL USE. DIAGNOSTIC OR TROUBLESHOOTING WAS PERFORMED IN THE FORM OF IMPEDANCE TESTING AND REPROGRAMMING. ACTIONS REQUIRED AS A RESULT OF THE EVENT CONSISTED OF SYSTEM EXPLANT AND REPLACEMENT. THE PATIENT¿S DEVICE WAS RETURNED FOR ANALYSIS. THE PATIENT¿S SYSTEM WAS PROVIDING RELIEF OF HER SYMPTOMS AND THAT PATIENT RECOVERED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION IS DEEMED NECESSARY AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367304 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention