BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2707313 · Received August 21, 2012

    Report

    Report Number
    3004209178-2012-07130
    Event Type
    Malfunction
    Date Received
    August 21, 2012
    Report Date
    July 23, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3093-28, LOT# V000231, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE STOPPED WORKING A COUPLE OF YEARS AGO. THE PATIENT STATED THAT HER "DEVICE WORKED AT THE BEGINNING." THE PATIENT FURTHER STATED THAT HER DEVICE HAD NOT BEEN CHECKED SINCE IMPLANT AND THAT SHE WAS EXPERIENCING LEAKING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY, BUT SHE WAS WORKING WITH HER PHYSICIAN AND MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD A SCHEDULED APPOINTMENT FOR (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1