BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3011493 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03938
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 28, 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
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V004103, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT IN THE POCKET AREA, "HER RIGHT ILIAC CREST AREA", AND THERE WAS A POWER ON RESET (POR) CONDITION FOLLOWING ELECTROMAGNETIC INTERFERENCE (ERI). THE CALLER (HEALTHCARE PROVIDER, HCP) ASSESSED THE POCKET AND BELIEVED SHE FELT A LEAD WIRE SUPERFICIALLY. THE HCP STATED THAT THE PAIN WAS NOT DEVICE RELATED AND IT "APPEARED TO BE THE VALVE BETWEEN THE LARGE AND SMALL INTESTINE." IT WAS STATED THAT THE PATIENT'S DEVICE WAS OFF AT THE TIME OF REPORT. IT WAS ALSO STATED THAT THE PATIENT HAD A STROKE IN (B)(6) 2012 THEN HAD AN MRI. REPORTEDLY, THE FACILITY WAS UNAWARE THE PATIENT HAD AN IMPLANTED DEVICE. FOLLOWING THIS STROKE WAS WHEN THE POR CONDITION OCCURRED AS WELL AS THE RETURN OF SYMPTOMS. THE HCP SUSPECTED THE MRI HAD SHIFTED THE INS/LEAD/EXTENSION. THE HCP ASKED THE PATIENT TO TURN ON HER DEVICE TO PROGRAM 1 BUT TURN DOWN TO 1 VOLT FROM 1.6 VOLTS PRIOR TO TURNING ON. IT WAS NOTED THAT THE PATIENT THEN FELT OVERSTIMULATION AND PRESSED THE EMERGENCY OFF BUTTON. THE PATIENT TURNED THE STIMULATION DOWN TO 0 VOLTS AND TURNED OFF THE DEVICE UNTIL ANOTHER HCP COULD ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114341 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1