BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4020002 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-15501
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 11, 2014
    Report Date
    October 22, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0J956, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN ADDITION TO INCONTINENCE, THE PATIENT HAD NOT HAD RELIEF OF FREQUENCY SINCE IMPLANT. THE PATIENT HAD SEEN THE REPRESENTATIVE TWO WEEKS AFTER IMPLANT FOR PROGRAMMING CHANGES AND ¿ONE OTHER TIME¿ TO CHANGE THE PROGRAM. IT WAS NOTED THE PATIENT HAD A URINARY TRACT INFECTION WHICH COULD HAVE BEEN CONTRIBUTING TO THEIR SYMPTOMS. NO INTERVENTION WAS NOTED AND NO OUTCOME WAS PROVIDED WITH THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. AN ADDITIONAL FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TRIAL THE PATIENT HAD SOME IMPROVEMENT AND THEY FELT IT WAS ENOUGH TO GO FORWARD WITH THE PERMANENT IMPLANT. SINCE IMPLANT, THE PATIENT HAD AN OVERSTIMULATION SENSATION AND STIMULATION KEPT REVVING UP ON ITS OWN AT DIFFERENT TIMES AND WAS VERY UNCOMFORTABLE. STIMULATION SEEMED TO BE CHANGING, SOMETIMES AFTER THE PATIENT SHOWERED, SAT IN A CAR, OR LAY DOWN. THE PATIENT¿S TOES WERE ¿CRAMPING UP LIKE CHARLIE HORSES¿ AND SHE HAD NOT OBTAINED THE DESIRED THERAPY BENEFIT. ESPECIALLY AT NIGHT, THERE WERE FIVE OR SIX TIMES IN A ROW WHERE THE PATIENT WAS LOSING CONTROL OF THE BLADDER. THE PATIENT WASN¿T ABLE TO GET IN FOR A FOLLOW-UP APPOINTMENT UNTIL THE WEEK FOLLOWING THE REPORT. IT WAS LATER REPORTED THAT THE PATIENT HAD A RECHARGEABLE DEVICE AND WAS GETTING SPONTANEOUS INCREASES IN STIMULATION, IT WAS CAUSING PAIN, AND SHE WAS STILL HAVING INCONTINENCE. HER DOCTOR¿S OFFICE SAID THIS WAS NOT NORMAL AND THEY WEREN¿T SURE WHAT WAS HAPPENING. THE PATIENT WAS WORRIED AND CONCERNED THE IMPLANT WAS DEFECTIVE. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT HAD AN APPOINTMENT WITH A PHYSICIAN¿S ASSISTANT THE PAST WEEK AND THE PHYSICIAN¿S ASSISTANT WAS UNABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) TO CHANGE A PROGRAM AFTER SEVERAL ATTEMPTS. THE CLINIC WAS TO GET BACK TO THE PATIENT BUT SHE HADN¿T HEARD ANYTHING. THE PATIENT HAD PAIN IN THE LOWER BACK NEAR THE SACRAL NERVE AND WAS CONCERNED THAT MAYBE THE IMPLANT HAD MOVED. SHE THOUGH THE DEVICE SHOULD BE REMOVED AND CHECKED IF THE INS MAY BE MALFUNCTIONING AND WAS CONCERNED ABOUT ANY INJURY THAT MAY OCCUR OR HAS OCCURRED. THE PATIENT¿S LOWER BACK WAS HOT AND BURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE MANUFACTURERS REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS TRYING TO CHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS) BUT IT DID NOT GO PAST 25%. THE PATIENT TRIED CHARGING IT FOR 1-1.5 HOURS AND IT REMAINED FLASHING AT 25%. THE PATIENT NOTED THAT SHE GOT ALL 8 COUPLING BARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499030 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention