BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3072890 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06759
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 3, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V583008, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PATIENT FELT HER LEADS WERE MOVING WHILE SHE WAS PREGNANT AND IT ENDED UP BEING PAINFUL. THE PAIN WAS IN HER BACK. IF THE PATIENT SAT DOWN SHE FELT SOMETHING WOULD CATCH ON HER BACK. THE PATIENT FOUND OUT SHE WAS PREGNANT IN (B)(6) 2012 WHICH WAS 3 MONTHS AFTER SHE HAD ALREADY BEEN PREGNANT. THE PATIENT WAS TIRED OF THE PAIN IN HER BACK AND HER LEADS MOVING THAT SHE JUST DECIDED TO HAVE DEVICE TAKEN OUT. THE PATIENT BELIEVED THE HEALTH CARE PROVIDER TOOK OUT BOTH INS AND LEADS BUT COULDN'T SAY FOR CERTAIN. THE PATIENT WAS SUPPOSED TO SEE THEIR HEALTHCARE PROVIDER ABOUT HER DEVICE A FEW WEEKS AFTER SHE FOUND OUT SHE WAS PREGNANT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    AFTER ADDITIONAL REVIEW, THE IMPLANT WAS REMOVED BECAUSE THE PATIENT WAS PREGNANT. IT WAS NOTED THAT THE PATIENT LOSS WEIGHT AND GAINED WEIGHT SO MUCH THAT IT MOVED ALL THE TIME AND INSTEAD OF GOING TO GET IT FIXED TO WHERE IT WAS MORE SECURE THE PATIENT HAD IT TAKEN OUT. IT WAS NOTED THAT THE PATIENT THINK IT WAS MORE THE LEADS THAT WAS MOVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174277 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention