BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3140323 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08479
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V850462, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INS BATTERY DEPLETION WAS PREMATURE. WHEN THE PATIENT LAST MET WITH HER DOCTOR, THEY SAID HER BATTERY WAS 28-47% USED AND IT HAD ONLY BEEN A YEAR. THE PATIENT'S BATTERY WAS DEPLETING FASTER THAN SHE THOUGHT IT WOULD. IT WAS DISCUSSED LONGEVITY DEPENDS ON PARAMTERS AND SETTINGS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS REMOVED SINCE IT WAS ¿NOT WORKING¿ AND THE PATIENT NEEDED AN MRI. IT WAS UNKNOWN IF THE INITIAL ALLEGATION AGAINST THE BATTERY DEPLETION WAS A CONTRIBUTING FACTOR TO THE REMOVAL OF THE DEVICE. THE PATIENT OUTCOME OF THE REMOVAL WAS NOT KNOWN. REFER TO MANUFACTURER REPORT #3004209178-2013-08445 FOR INFORMATION REGARDING THE DEVICE ¿NOT WORKING¿ AND MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241359 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention