BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2924610 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00803
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    August 7, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V054682, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT# V017147, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BATTERY DEPLETED NOT VERY LONG AFTER THE PATIENT GOT IT PUT IN, AND THE PHYSICIAN RECOMMENDED PLACING TWO BATTERIES AT THE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT # 3004209178-2013-00802. IT WAS UNCLEAR WHICH DEVICE WAS RELATED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT DID NOT WORK FOR THEM AND THE BATTERY DIED AND WAS REPLACED. SEE MANUFACTURER REPORT #3004209178-2013-00802 PATIENT HAS MULTIPLE DEVICES AND IT IS UNCLEAR WHICH DEVICE PERTAINED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30906 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention