BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3002318 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03654
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA02241, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT FEEL ANY STIMULUS. PATIENT HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT WAS HAVING GOOD RESULTS ON PROGRAM 4 AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL TWICE ON (B)(6) 2013. IT WAS FURTHER REPORTED THAT THE PATIENT 'BROKE HER FOOT IN TWO PLACES. IT WAS ALSO REPORTED THAT THE PATIENT COULD 'NOT STAND UP PROPERLY' FOLLOWING THE FALLS. IT WAS STATED THAT 'THE MINUTE' SHE WOULD STAND UP THAT SHE WOULD 'NEED TO GO TO THE BATHROOM RIGHT AWAY.' IT WAS REPORTED THAT PRIOR TO THE FALLS THAT THE PATIENT SEEMED 'TO BE FINE.' IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS 'NOT ABLE TO COMMUNICATE' WITH HER DEVICE. X-RAY TESTING REVEALED THAT THE PATIENT'S ANKLE WAS 'BROKEN IN TWO PLACES.' THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105524 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR