BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3002955 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03686
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # VA057LW, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT. IT WAS ALSO REPORTED THE PATIENT SUFFERS FROM URINARY TRACT INFECTIONS (UTI) AND HAS SEIZURES WHEN SHE "GETS CONFUSED FROM AN ELDERLY UTI." IT WAS REPORTED THE PATIENT BEGAN TO FEEL PAIN FROM THE IMPLANTABLE NEUROSTIMULATOR WHILE RIDING IN A CAR ON (B)(6) 2013. THE PATIENT REPORTEDLY WAS UNABLE TO GET BACK INTO THE CAR UNTIL THE STIMULATION AMPLITUDE WAS DECREASED. IT WAS REPORTED THE PATIENT DECREASED THEIR AMPLITUDE FROM 2.9 AMPS TO 2.6 AMPS AND THEN DOWN TO 2.0 AMPS AND AVOIDED SITTING ON THE PAINFUL AREA. IT WAS ALSO REPORTED THE PATIENT WENT INTO A SEIZURE ON (B)(6) 2013 AFTER TURNING THE AMPLITUDE DOWN TO 2.0 AMPS AND WOKE UP FEELING "FINE" ON (B)(6) 2013. THE PATIENT REPORTEDLY INCREASED THE AMPLITUDE BY 0.1 AMPS PER DAY AND WAS SET AT 2.5 AMPS ON THE DATE OF REPORT. IT WAS REPORTED THE PATIENT FELT PAIN WHILE LYING DOWN THE NIGHT PRIOR TO REPORT AND "COULD NOT TURN OVER" SO THE PATIENT DECREASED THE AMPLITUDE TO 2.3 AMPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) NOTED THAT THE PATIENT HAD A HISTORY OF SEIZURES PRIOR TO THE IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE HCP ALSO NOTED THAT THE EVENT WAS UNLIKELY DUE TO PROGRAMMING ISSUES. IT WAS CONFIRMED THAT THE PATIENT'S INCONTINENCE AND ASSOCIATED UTIS CONTRIBUTED TO THEIR SEIZURE DISORDER BUT THAT THEY WERE NOT "DE NOVO" FROM THE INS. HOSPITALIZATION WAS NOT REQUIRED FOR THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. ADDITIONAL FOLLOW UP INFORMATION RECEIVED 7 DAYS LATER REPORTED THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR AND MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED HOWEVER THAT FECAL INCONTINENCE ISSUE CONTINUED FOR THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104842 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention