BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4468578 · Received January 30, 2015

    Report

    Report Number
    3004209178-2015-01467
    Event Type
    Injury
    Date Received
    January 30, 2015
    Report Date
    January 27, 2015
    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 MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V122742, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT, GRADUALLY OVER TIME. THE PATIENT HAD NOT CHANGED THE PROGRAM OR AMPLITUDE AT ALL IN SEVERAL YEARS. THE PATIENT INCREASED THE AMPLITUDE AND WOULD SEE HOW THE NEXT FEW DAYS WENT. THE PATIENT WOULD CONTACT THEIR HEALTH CARE PROVIDER (HCP) IF THEY NEEDED TO MEET WITH THE MANUFACTURER REPRESENTATIVE. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT SEE THEIR HCP AND DID NOT DISCUSS THEIR EVENT WITH A MANUFACTURER REPRESENTATIVE. THE PATIENT STILL HAD PROBLEMS WITH THEIR SYSTEM. IT WAS LATER REPORTED THAT THE PATIENT¿S FIRST DEVICE FAILED. THE PATIENT HAD THEIR SYSTEM REPLACED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70485 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention