BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2580490 · Received May 18, 2012

    Report

    Report Number
    3004209178-2012-03487
    Event Type
    Injury
    Date Received
    May 18, 2012
    Report Date
    April 24, 2012
    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

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V536681, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE BATTERY, MODEL #3058/SERIAL # (B)(4) , FOUND NO SIGNIFICANT ANOMALY. THE BATTERY FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD, MODEL #3889-28, FOUND THE LEAD BODY CONDUCTOR BROKEN AT OR NEAR THE TINES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPROGRAMMING DID NOT RESOLVE THE ISSUE. DURING THE SURGICAL PROCEDURE, THE LEAD WAS TESTED TO SEE IF ANY STIMULATION WAS FELT. THE STIMULATION WAS TURNED UP TO THE MAXIMUM ON ALL FOUR ELECTRODES (0,1,2 AND 3) AND STILL NO STIMULATION WAS FELT. THE PATIENT DID REPORT ONE FALL IN THE PAST. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST THERAPEUTIC EFFECT 3 WEEKS PRIOR TO REPORT. DURING A REVISION PROCEDURE, IT WAS DETERMINED THE LEAD "JUST STOPPED WORKING." THE PATIENT HAD THEIR DEVICE SYSTEM EXPLANTED. IT WAS ALSO STATED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN GOING THROUGH SECURITY GATES, WHICH HAD INCREASED IN FREQUENCY OVER THE SIX MONTHS PRIOR TO REPORT. IT WAS DESCRIBED AS A "VAGINAL ZAP." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention