BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3161421 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10121
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 15, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: EXTENSION: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-28, LOT# J0542891V, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE BLADDER INFECTION WAS UNRELATED TO THE DEVICE. THE CAUSE OF THE EVENT WAS UNKNOWN AND NO HOSPITALIZATION WAS REQUIRED. IT WAS STATED THE PATIENT HAD NOT BEEN SEEN BY THE HEALTHCARE PROVIDER SINCE 2005. A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT'S BACK WAS HURTING. IT WAS NOTED THAT THE PATIENT SAW A SCREEN ON THEIR PROGRAMMER THAT WAS AN ARROW POINTING TO A STRIPE AND THEN A SIDEWAYS BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BELIEVED SHE WOKE UP THIS MORNING ((B)(6) 2013) WITH A BLADDER INFECTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263056 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other