BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3092329 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07270
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-28, LOT # VA0315Y, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # VA0315Y, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE; APPT 2013 (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAST THURSDAY, THE PATIENT FELT A "TERRIFIC" ELECTRIC JOLT WITH SEVERAL LESSER JOLTS IN THE EVENING, AND THE AREA WAS SORE FOR A COUPLE OF DAYS AFTERWARD. IT WAS NOTED THAT EVEN BEFORE IMPLANTS, THE PATIENT HAD ELECTRIC JOLTS IN HER GROIN AND THE PATIENT'S HCP (HEALTH CARE PROFESSIONAL) TOLD THE PATIENT IT WAS ARTHRITIS AND THAT IT SOUNDED LIKE "JUST NERVES." THE PATIENT FOUND OUT SHE HAD INADVERTENTLY TURNED ONE DEVICE OFF FOR ABOUT A MONTH, SHE DID NOT NOTICE A CHANGE IN THE SYSTEM, AND HAD NOT RECEIVED ANY JOLTING/SHOCKING SINCE. THE PATIENT WAS WAITING TO SEE THE MANUFACTURER REPRESENTATIVE TO GET THE DEVICE "UP AND RUNNING" FOR MAXIMUM RELIEF OF HER SYMPTOMS, AS SHE HAD SOME RELIEF BUT NOT TOTAL RELIEF. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2013-07269.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195095 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR