BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2866426 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11658
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 17, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V242434, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD RECEIVED ASSISTANCE OVER THE PHONE FROM HER DOCTOR OR COMPANY REPRESENTATIVE AND HER CONCERNS HAD BEEN RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL STIMULATION SENSATION. APPROXIMATELY 4 MONTHS BEFORE, THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) REPROGRAMMED. APPROXIMATELY A WEEK PRIOR, THE PATIENT FELL ON HER BUTTOCK AND HER HEALTHCARE PROVIDER (HCP) HAD BEEN NOTIFIED OF THE FALL. IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT ADJUST STIMULATION WITH HER PATIENT PROGRAMMER. THE INS WAS OFF AT THE TIME BUT IT WAS LATER TURNED ON. THE PATIENT'S SETTING WAS CHANGED TO 1.3V; AND IT WAS NOTED SHE COULD FEEL THE STIMULATION WELL BUT IT WAS NOT PAINFUL OR UNCOMFORTABLE IN THE PELVIC AREA OF HER BODY. THE FOLLOWING DAY, THE PATIENT'S STIMULATION AMPLITUDE WAS DECREASED TO 0.6V AND SHE FELT MORE COMFORTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1