BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4133340 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18074
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0AWZE, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WAS NO INFORMATION ON THESE CLAIMS AS THE PATIENT HAD NOT REPORTED ANY RESPIRATORY DISTRESS OR FLUID RETENTION ISSUES TO THEM. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN REMOVED, THE PATIENT WAS SUPPOSED TO SUPPLY SOME INFORMATION FROM ONE OF HER HEALTH CARE PROVIDER (HCP) GIVING A REASON FOR REMOVAL. THE PATIENT HAD NOT PROVIDED ANY DOCUMENTATION TO HCP. IT WAS ASSUME THE PATIENT WAS FINE AS THEY HAVE NOT HEARD FROM HER IN THE LAST FEW WEEKS. IT WAS REPORTED A DAY LATER THAT THE HCP RECEIVED A MEDICAL REQUEST FROM ANOTHER UROLOGIST IT SEEMED SHE HAD SEEN TWO SINCE SHE HAD BEEN WITH HCP. THE HCP HAD A RECORD INDICATING WHEN PATIENT CAME IN, SHE REPORTED SOME RECURRENT URINARY TRACT INFECTIONS (UTI'S) WHICH HAD BE DISCUSSED EARLIER JUST VERY RIGHT AFTER PATIENT WAS IMPLANTED WITH THE INTERSTIM, HOWEVER PATIENT HAD DEVICE REMOVED ON (B)(6) 2014 BY ANOTHER HCP AND WAS CURRENTLY GOING TO ANOTHER CLINIC WHERE SHE HAD REQUESTED HER RECORDS. IT WAS REPORTED LATER ON THE DAY OF THIS CALL THAT AFTER THE REMOVAL, THE HCP PROVIDED INFORMATION THAT THE DEVICE WAS FINE, LEAD WAS PLACED CORRECTLY, AND THERE WAS NO INFECTION. THE PATIENT HAD REQUESTED REMOVAL SO THE OTHER HCP REMOVED IT AND GAVE PATIENT A BOTOX INJECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE DEVICE AND THERAPY HAD NOT WORKED FOR HER SINCE IMPLANT. THE PATIENT REPORTED HAVING MULTIPLE SCLEROSIS (MS), THE DISEASE HAD DESTROYED HER BLADDER, AND SHE WAS HAVING SOME MEDICAL COMPLICATIONS RELATED TO THE DEVICE. HER IMMUNE SYSTEM WAS WEAK BECAUSE OF MS AND ALL OF THE OTHER PROBLEMS. PRIOR TO IMPLANT THE PATIENT WAS RELEASING URINE, BUT SINCE IMPLANT SHE WAS HOLDING 800 CC UNITS. HER BODY WAS HOLDING FLUIDS SINCE IMPLANT AND SHE HAD SWELLING IN HER HANDS, FACE, AND FEET. IT FELT LIKE NEEDLES WERE POKING THE PATIENT IN HER BLADDER AND THEN THE BLADDER WOULD RELEASE THE URINE. THE PATIENT HAD MORE PAIN IN HER BLADDER, THERAPY WAS NOT HELPING WITH HER BLADDER SPASMS, AND SHE WAS WAKING UP IN RESPIRATORY DISTRESS. THE PATIENT WAS HOSPITALIZED ON ONE OCCASION FOR RESPIRATORY DISTRESSED AND THE EMERGENCY ROOM DIAGNOSED THAT THE PATIENT HAD FIVE URINARY TRACT INFECTIONS (UTIS) SINCE IMPLANT. SHE WAS IN THE HOSPITAL ON (B)(6) 2014 FOR A UTI. PRIOR TO THE IMPLANT THE PATIENT HAD NOT HAD A UTI IN OVER A YEAR. ORAL ANTIBIOTICS DID NOT WORK TO TREAT THE UTI AND THE UTI AFFECTED HER BRAIN. THE PATIENT STATED THAT MS IMPACTED ALL AREAS OF HER LIFE AND HER BRAIN WAS COVERED WITH LESIONS. THE PATIENT¿S NEUROLOGIST WANTED THE DEVICE REMOVED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611089 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R