BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2710370 · Received August 22, 2012

    Report

    Report Number
    3004209178-2012-07230
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 27, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V973942, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(6). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION IN THEIR CHEST AREA BY THE SHOULDER FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THIS OCCURRED THE FIRST COUPLE OF DAYS AFTER IMPLANT. IN ADDITION, THE PATIENT WAS SHOCKED ONCE IN THE BUTTOCK AREA. IT WAS REPORTED THAT OTHER THAN THE SHOCKING THE PATIENT "LOVES THE DEVICE." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INDICATED THAT PHYSICIAN SAW THE PATIENT 'RECENTLY' AND HAD NOTHING OF REMARKABLE TO REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAD A WET EPISODE AFTER IMPLANT AND SHOCKING IN HER CHEST. THE PATIENT WAS STILL HAVING CONCERNS REGARDING TO HER DEVICE OR THERAPY BUT SHE WAS WORKING WITH HER DOCTOR OR MANUFACTURER'S REPRESENTATIVE. THE PATIENT WAS SCHEDULED TO SEE THE DOCTOR ON (B)(6) 2012. THE PATIENT HAD REPROGRAMMED WITH MANUFACTURER'S REPRESENTATIVE ON (B)(6) 2012. PATIENT MANAGEMENT WORKSHEET INDICATED THAT PROGRAM 1 = RECTUM AND PROGRAM 3 = CHEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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 00060 YR