BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3775682 · Received April 28, 2014

    Report

    Report Number
    3004209178-2014-08174
    Event Type
    Injury
    Date Received
    April 28, 2014
    Report Date
    April 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# V238369, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V241897, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN (B)(6) OF 2009 THAT THE PATIENT NOTED THAT STIMULATION WAS NOT LIKE IT WAS IN THE BEGINNING. IT WAS STILL WORKING HOWEVER JUST NOT AS STRONGLY. IT WOULD HELP A LITTLE IN THE BEGINNING AND THAN IT SEEMED AS THOUGH IT FADES. IT WAS ALSO NOTED IMPLANTABLE NEUROSTIMULATOR (INS) SEEMED TO BE BULGING OUT OF BACK. IT WAS NOTED NOT THAT PAINFUL OR REDNESS OR SWELLING AT AREA. FROM REPORTING (B)(6) 2009 IT WAS NOTED THAT THE PATIENT HAD NOT SEEN THEIR DOCTOR ABOUT THE EVENT. THEY DID DISCUSS IT WITH A MANUFACTURER'S REPRESENTATIVE. THE PATIENT WAS STILL HAVING PROBLEMS WITH THEIR SYSTEM. IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE PATIENT'S FIRST DEVICE ONLY WORKED RIGHT IN THE VERY BEGINNING. 2 YEARS AGO THE PATIENT WAS TOLD HER LEADS WERE DISCONNECTED. THE PATIENT HAD REVISION AND BATTERY REPLACEMENT SURGERY ON (B)(6), 2014. THE SURGERY ON (B)(6), 2014 WAS TO REATTACH DISCONNECTED LEADS AND RE-IMPLANT A NEW BATTERY. THE BATTERY HAD DIED AND NEEDED TO BE REPLACED. BATTERY REPLACEMENT WAS DUE TO REGULAR BATTERY LONGEVITY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT BELIEVED THEY REPLACED BOTH THE LEADS AND THE INS ON (B)(6) 2014. THE INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT DIDN'T KNOW IF BOTH THE INS AND LEADS WERE REPLACED. TWO OF THE LEADS WERE DISCONNECTED/BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254827 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention