BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2725296 · Received September 4, 2012

    Report

    Report Number
    3004209178-2012-07634
    Event Type
    Malfunction
    Date Received
    September 4, 2012
    Report Date
    August 3, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V192314, 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

    IT WAS REPORTED THAT IN THE PAST 10 MINUTES WHEN THE PATIENT BENT OVER AND THEN STOOD UP THEY FELT THEIR BACKSIDE CRACK. THEY THEN HIT THE SIDE OF A MARBLE CABINET DIRECTLY ONTO THE SITE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AT WHICH TIME THEY FELT PAIN AND A CHANGE IN THEIR STIMULATION. THERE WAS ALSO A "BRIGHT RED" SPOT OVER THE INS SITE WHICH FELT HOT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT IS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAS NOT SOUGHT FURTHER HELP FROM HER HEALTH CARE PROVIDER (HCP).

    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