BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4090742 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17070
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3889-33, LOT# VA0K1AV, IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. 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 A PATIENT WAS HAVING PROBLEMS WITH HER IMPLANTABLE NEUROSTIMULATOR (INS), HAD PAIN AND ACHING, AND NEVER HAD THERAPEUTIC EFFECT SINCE THE TIME OF IMPLANT. THE PATIENT HAD A LOT OF PAIN THAT WENT DOWN FROM THE BACK OF HER HIP TO THE BEND OF HER KNEE. HER LEG ACHED WHETHER THE DEVICE WAS ON OR OFF. THE PATIENT SPOKE WITH A MANUFACTURER REPRESENTATIVE ON 2014-(B)(6), WHO HELPED HER CHANGE THE PROGRAM, WHICH HELPED THE PAIN THAT WENT DOWN TO HER TOES BUT DIDN¿T ELIMINATE ALL OF IT. THE PATIENT DIDN¿T KNOW IF IT WAS SUDDEN OR GRADUAL. THE PATIENT DIDN¿T THINK THAT THE DEVICE HAD EVER BEEN PROGRAMMED CORRECTLY AND SHE FELT WHEN IT WAS PUT IN, IT WAS PROGRAMMED TO BE TOO STRONG. ON (B)(6)-2014, THE PATIENT COULD FEEL WHERE THE PAIN WAS, BUT PREVIOUSLY IT WAS SO STRONG THAT SHE COULDN¿T TELL IT WAS HURTING. STIMULATION WAS TURNED OFF THE NIGHT OF (B)(6)-2014 BECAUSE IT WAS ¿HURTING HER SO BAD.¿ THE PATIENT FELT LIKE THE THERAPY WAS GOING TO WORK FOR HER; SHE JUST DIDN¿T WANT TO BE IN PAIN ALL THE TIME. THE DEVICE WAS ON PROGRAM 2 AT 0.65 VOLTS AND THE PATIENT HAD ALREADY TRIED PROGRAMS 3 AND 4 AND WAS STILL PAIN. THE PATIENT FELT SHE NEEDED TO MAKE AN APPOINTMENT WITH HER HEALTHCARE PROVIDER AND A MANUFACTURER REPRESENTATIVE AND SHE WANTED HELP WITH REPROGRAMMING. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED BUT NOTED IT WAS NOT RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). AT THE REQUEST OF THE HEALTHCARE PROFESSIONAL (HCP), THE MANUFACTURER¿S REPRESENTATIVE CONTACTED THE PATIENT AND HELPED THEM SWITCH THE PROGRAMS OVER THE PHONE. THE PATIENT DID HAVE GREATER THAN 50 PERCENT REDUCTION IN THEIR SYMPTOMS AND THEY WERE FINE. IT WAS LATER REPORTED THAT THE PATIENT LACKED BASIC UNDERSTANDING OF THEIR THERAPY. THE PATIENT STATED THEY NEEDED TO HAVE THEIR DEVICE REPROGRAMMED AND THEY NEVER HAD THERAPEUTIC EFFECT. THE PATIENT STATED IT ONLY WORKED FOR A COUPLE WEEKS AND THEIR UROLOGIST TOLD THE PATIENT THEY WEREN¿T EMPTYING THEIR BLADDER. IT WAS MENTIONED THAT THE PATIENT¿S TRIAL LASTED 5 DAYS AND IT WAS FINE. SINCE RECEIVING THEIR IMPLANT THE PATIENT HAD TWO INFECTIONS AND WAS ON ANTIBIOTICS AT THE TIME OF THIS REPORT. THE PATIENT WAS NOT FEELING STIMULATION AT THE TIME OF REPORT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT'S LAST VISIT WAS (B)(6) 2014 AND AT THAT TIME THEY HAD NO INFECTION AND THE INCISION SITE WAS WELL-HEALING. THE PATIENT STATED THEY WERE "FEELING BETTER THAN SHE HAS FELT IN A LONG TIME." THE PATIENT HAD NO COMPLAINTS OF RETENTION OR ANY MORE URINARY TRACT INFECTIONS. THE PATIENT HAD THEIR DEVICE REPROGRAMMED LAST ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569501 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention