BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4200445 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20363
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 29, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# V000231, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION. STIMULATION QUIT WORKING THE DAY PRIOR TO CALL. TWO WEEKS LATER, THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. A MANUFACTURER REPRESENTATIVE¿S NAME WAS NOTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED LATER INDICATED THAT PATIENT WAS SCHEDULED FOR BATTER REPLACEMENT AND POSSIBLE LEAD REVISION. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED LATER INDICATED THE REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION ON (B)(6) 2014 AND NO OTHER ADDITIONAL TROUBLESHOOTING OR INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678187 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention