BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4012542 · Received August 15, 2014

    Report

    Report Number
    3004209178-2014-15380
    Event Type
    Injury
    Date Received
    August 15, 2014
    Report Date
    July 21, 2014
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND THAT THE INS BATTERY HAD REACHED NORMAL END OF LIFE WITH NO TELEMETRY AND NO OUTPUT.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. CONCLUSION CODES HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V351473, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# V041106, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT GOT INTO A CAR ACCIDENT AND HAD DAMAGE TO THE LEFT SIDE OF THE BODY WHERE THE LEAD WAS. THE PATIENT HAD SYMPTOM RETURN AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEAD, SO THEY COULD NOT BRING UP TO TROUBLESHOOT. THE INS HAD NORMAL BATTERY DEPLETION AND HAD BEEN IMPLANTED FOR MANY YEARS AND JUST HADN'T BEEN REMOVED. IT WAS COMPLETELY END OF SERVICE (EOS) ON THE DAY OF REMOVAL AND THE MANUFACTURER REPRESENTATIVE COULDN'T INTERROGATE IT. THE LEFT INS AND LEAD WERE REMOVED ON (B)(6) 2015 AND WERE NOT REPLACED. THE ISSUE WAS RESOLVED AND THE PATIENT WAS ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    IT WAS LATER INDICATED THAT THE SYMPTOM OCCURRED FOLLOWING SOME FORM OF TRAUMA AND WAS INDICATED AS A GRADUAL ONSET. THE PATIENT WAS ECSTATIC WHEN SHE GOT SECOND NEUROSTIMULATOR (INS) FOR INTERSTIM BECAUSE SHE WENT FROM HAVING BLADDER OF 80 YEARS OLD BACK TO 30 YEARS OLD BLADDER. THE PATIENT WAS HAVING WEIRD MEDICAL ISSUES COME UP SLOWLY AND WAS TRYING TO FIGURE OUT IF IT CORRELATES WITH PATIENT DAMAGING THE UNIT. THE PATIENT STATED HER IMMUNE SYSTEM WAS BEING COMPROMISED AND THEY COULD NOT FIGURE OUT WHY. IT WAS REPORTED THAT PATIENT KEPT GETTING PNEUMONIA AND OTHER WEIRD KIND OF THINGS. THE STATED SHE WAS FROM A MEDICAL BACKGROUND AND IMMUNE SYSTEM WAS GOING TO RECOGNIZE ANYTHING PUT IN THE BODY AS A FOREIGN OBJECT JUST LIKE HER BLADDER WILL BE AFFECTED BY SOMETHING THAT WAS NOT WORKING. THE PATIENT STATED THAT CURRENTLY KIDNEYS ARE FAILING; PNEUMONIA AND BLOOD LEVELS ARE ALL OUT OF WHACK, ULCERS IN PATIENT'S MOUTH THAT HAD NOT GONE AWAY AND PATIENT HAD NOT BEEN ABLE TO EAT FOR THREE WEEKS. THE PATIENT INDICATED THAT ALL THESE SYMPTOMS HAD COME TOGETHER AND HIT HER AT ONCE. THE HCP DID NOT THINK THEY NEED TO BE TAKEN OUT UNLESS BATTERY ON UNDERSIDE NEEDED TO BE CHANGED. IT WAS INDICATED THAT THE LAST TIME PATIENT SAW THE HCP WAS COUPLE OF WEEKS AFTER SHE GOT HOME FROM BEING IN THE HOSPITAL FROM CAR ACCIDENT IN (B)(6) 2012.

    Description of Event or Problem · 1

    THE PATIENT INDICATED THAT SHE HAS 2 NEUROSTIMULATOR (INS) AND THE ONE ON THE LEFT SIDE WAS DAMAGED AND HASN'T WORKED IN ALMOST 2 YEARS. THE PATIENT WAS INQUIRED IF SHE COULD USE HER PROGRAMMER THAT SHE HAD FROM HER DAMAGED INS AND HAVE IT PROGRAMMED TO WORK WITH THE WORKING INS ON THE RIGHT SIDE. THE PATIENT REPORTED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED SHE WAS INVOLVED IN A BAD CAR ACCIDENT ON (B)(6) 2012 AND MOST OF THE IMPACT WAS ON THE LEFT SIDE. IT WAS INDICATED THAT SINCE THE ACCIDENT, HER INS ON HER LEFT SIDE HAS NOT WORKED. IT WAS INDICATED THE PATIENT FOLLOWED UP WITH THEIR HEALTH CARE PROVIDER BUT HE DID NOT WANT TO REPLACE OR TAKE OUT THE INS UNTIL SHE HAS THE OTHER INS REPLACED. IT WAS CONFIRMED AT THE TIME OF THE APPOINTMENT WITH THE MANUFACTURER REPRESENTATIVE THAT TIME THE INS WAS NO LONGER WORKING. IT WAS INDICATED THAT THE PATIENT HEALTH CARE PROVIDER WAS SAYING HE WILL PROBABLY GO IN AND PULL OUT THE LEFT INS SINCE IT WAS NOT WORKING. IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE PATIENT WAS LAST SEEN AT THE END OF MAY. THE HEALTH CARE PROVIDER STATED THE LEFT DEVICE HAD NOT BEEN WORKING SINCE THE PATIENT WAS IN A CAR ACCIDENT, BUT THE PATIENT CONTINUED TO USE THE RIGHT SIDE INS. IT WAS INDICATED THAT THE RIGHT SIDE DEVICE WAS HELPING WITH THE PATIENT¿S SYMPTOMS IN SOME WAYS, BUT PATIENT WOULD STILL LIKE TO IMPROVE. IT INDICATED THAT HCP DID NOT KNOW IF PATIENT WAS GETTING GREATER THAN 50% SYMPTOM REDUCTION. THERE WAS NO TROUBLESHOOTING DONE ON THE DEVICE. THE PATIENT OUTCOME WAS NOT REPORTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490758 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Other| R