BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM TINED LEAD

    MDR report key: 1010225 · Received February 10, 2008

    Report

    Report Number
    MW5005819
    Event Type
    Injury
    Date Received
    February 10, 2008
    Date of Event
    February 23, 2006
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A NEUROSTIMULATOR IMPLANTED. IT WAS CALLED A SACRAL NERVE STIMULATOR OR AN INTERSTIM UNIT. IT WAS IMPLANTED TO ALLEVIATE THE SYMPTOMS OF VOIDING DYSFUNCTION. THE VOIDING DYSFUNCTION INCLUDED URINARY RETENTION, URGENCY AND FREQUENCY. THE UNIT CONSISTED OF A LEAD WIRE CONNECTED TO A GENERATOR. THE GENERATOR DELIVERED ELECTRICAL PULSES THROUGH THE LEAD WIRE. THE ELECTRICITY WAS USED TO STIMULATE THE SACRAL NERVES, IN ORDER TO TRY AND CONTROL THE VOIDING DYSFUNCTION. ORIGINALLY, THE LEAD WAS PLACED ADJACENT TO THE 4TH SACRAL NERVE. THIS WASN'T VERY HELPFUL, SO A COUPLE OF YRS LATER, I HAD THE LEAD WIRE MOVED TO THE 3RD SACRAL NERVE. I STILL KEPT HAVING THE SYMPTOMS, SO THE LEAD WAS MOVED FROM THE 3RD SACRAL NERVE TO THE 2ND SACRAL NERVE. I WAS HOPING IT WOULD BE MORE EFFECTIVE AT THIS LEVEL. AT THE PRE-OPERATIVE APPOINTMENT, THE DOCTOR AND I AGREED THAT HE WOULD BE MOVING JUST THE LEAD, BUT RIGHT BEFORE THE SURGERY, THE DOCTOR CONVINCED ME TO REMOVE AND REPLACE THE GENERATOR, TOO. HE EXPLAINED THAT THE BATTERY IN THE GENERATOR WOULD NEED TO BE REPLACED IN A FEW YRS, SO RATHER THAN HAVING TO GO THROUGH ANOTHER SURGERY, I MIGHT AS WELL REPLACE IT THEN. I WAS THROWN A LITTLE AT FIRST BY HIS PROPOSAL, SINCE I'D ONLY HAD THE UNIT 5 YRS AND I HAD BEEN TOLD ORIGINALLY THAT THE BATTERY WOULD LAST 10 YRS, BUT HE SAID IT WOULD ONLY LAST 7 YRS. SO I TOOK HIS ADVICE AND HAD BOTH THE GENERATOR AND THE LEAD REMOVED. THEN, A NEW GENERATOR WAS IMPLANTED ALONG WITH A NEW LEAD LYING NEXT TO THE 2ND SACRAL NERVE INSTEAD OF THE 3RD. THIS WORKED WELL FOR ABOUT 5 DAYS AND THEN IT BECAME INFECTED. AS A RESULT, IT HAD TO BE REMOVED. I WAS PUT ON AN ANTIBIOTIC AND TOLD THAT I HAD TO WAIT FOR A COUPLE OF MONTHS BEFORE THE DOCTOR WOULD BE ABLE TO IMPLANT A NEW ONE. THE INFECTION CLEARED UP WITHIN A FEW WEEKS, SO WE WERE ABLE TO PROCEED WITH THE NEW IMPLANT AS PLANNED. I ASKED TO HAVE THE GENERATOR PLACED ON THE OPPOSITE SIDE OF THE SPINE THIS TIME, TO REDUCE THE CHANCE OF INFECTION. THIS NEUROSTIMULATOR WORKED PROPERLY. I DIDN'T HAVE AN INFECTION WITH IT. IT DIDN'T SEEM TO WORK AS WELL FOR THE VOIDING DYSFUNCTION AS THE FIRST ONE HAD (BEFORE IT BECAME INFECTED), THOUGH. SO A SERIES OF SESSIONS TOOK PLACE IN WHICH THE DEVICE WAS REPROGRAMMED. EVENTUALLY, WE REALIZED THAT THIS IMPLANT WAS NOT GOING TO BE VERY HELPFUL, EITHER. (BUT, AT LEAST IT WORKED A LITTLE BETTER THAN WHEN THE LEAD WAS PLACED NEXT TO THE 3RD SACRAL NERVE). I THEN WENT ON TO HAVE A COUPLE OF NERVE BLOCKS TO SEE IF THIS WOULD HELP WITH MY BLADDER FUNCTION. THESE WERE CALLED HYPOGASTRIC NERVE BLOCKS. SO, I WAS TO HAVE A SERIES OF 3 NERVE BLOCKS. THE FIRST ONE WENT WELL. IT HELPED TO REDUCE MY SYMPTOMS. I WAS SCHEDULED FOR THE SECOND ONE, WHEN I GOT A BLADDER INFECTION. SO, IT HAD TO BE POSTPONED. I THEN HAD BLADDER INFECTION ON AND OFF FOR A FEW MONTHS. THESE HAD CLEARED UP FOR SEVERAL MONTHS AND I WAS GOING TO HAVE ANOTHER NERVE BLOCK. THEN THE PAIN BEGAN WITH THE NEUROSTIMULATOR. IT WAS A BURNING, ACHING TYPE OF PAIN THAT PERIODICALLY SENT JOLTS AND SHOCKS FROM THE PLACE LEADS WERE AT, ACROSS MY BACK, THROUGH THE SITE WHERE THE GENERATOR HAD PREVIOUSLY BEEN IMPLANTED AND DOWN MY LEFT LEG. I CALLED THE REPRESENTATIVE FROM THE COMPANY BUT HE SAID HE COULDN'T REPROGRAM THE NEUROSTIMULATOR UNTIL THE PAIN ISSUE WAS RESOLVED. SO, I WENT TO SEE THE UROLOGIST. HE DIDN'T EVEN ATTEMPT TO FIND OUT WHAT WAS WRONG WITH IT. HE DIDN'T EVENT DO A SIMPLE X-RAY! I WANTED HIM TO FIND OUT WHAT WAS GOING ON WITH THE INTERSTIM UNIT, BUT HE INSISTED I NEEDED TO GO TO THE PAIN CLINIC. SO, I WENT TO THE PAIN CLINIC AND THE PAIN DOCTOR THOUGHT MAYBE THE SCIATIC NERVE HAD BEEN IRRITATED. HE SUGGESTED THAT I WAIT AND SEE ANOTHER DOCTOR THAT WAS COMING TO THE CLINIC IN ABOUT 6 WEEKS. SHE WAS A UROGYNECOLOGIST THAT HAD ALSO WORKED WITH THE INTERSTIM THERAPY. SURPRISINGLY, WHILE I WAS WAITING TO SEE THE DOCTOR HE'D RECOMMENDED, THE PAIN WENT AWAY. SO, I THOUGHT I WOULD BE ALRIGHT AND WAS RELIEVED TO SEE THAT THE PAIN HAD SUBSIDED. UNFORTUNATELY, THE PAIN CAME BACK A FEW MONTHS LATER. SO, THE REPRESENTATIVE DECIDED TO TRY AND REPROGRAM IT THIS TIME. IT WAS AT THIS POINT, HE REALIZED THAT THERE WAS NO ELECTRICAL PULSE COMING FROM THE GENERATOR, WHEN IT WAS SET ON THE THIRD ELECTRODE. HE DID AN IMPEDANCE TEST AND FOUND OUT THIS ELECTRODE HAD STOPPED WORKING. SO, HE MOVED THE STIMULATION TO ANOTHER LEAD. I WASN'T TOLD THAT THERE WAS ANYTHING ELSE WRONG WITH THE DEVICE. BOTH THE DOCTOR AND THE REPRESENTATIVE SAID THEY DIDN'T KNOW WHY I WAS HAVING PAIN. THEY JUST ASKED ME TO SEE IF I HAD PAIN WITH IT TURNED OFF, AS WELL AS HAVING PAIN WHEN IT WAS TURNED ON. SUPPOSEDLY, THIS WOULD HELP THEM DECIDE WHAT TO DO NEXT. THE DOCTOR BEGAN TO SUGGEST ALTERNATIVE THERAPY. HE ALSO TALKED ABOUT REMOVING THE LEAD VS. REMOVING THE ENTIRE IMPLANT. THEY KNEW THERE WAS A PROBLEM WITH THIS LEAD, BUT THEY CLAIMED THAT THEY DIDN'T KNOW ANYTHING MORE THAN THE FACT THAT THE ELECTRODE HAD STOPPED WORKING. THE REPRESENTATIVE REPROGRAMMED THE DEVICE AND I WAS SENT HOME TO SEE WHAT THIS WOULD DO. I WAS ALSO TOLD TO THINK ABOUT WHAT I WANTED TO DO NEXT. I WAS TOLD THAT I NEEDED TO DECIDE WHETHER IT WAS WORTH REPLACING THE LEAD WIRE OR WHETHER I THOUGHT I SHOULD JUST HAVE THE ENTIRE SYSTEM REMOVED AND GO WITH THE ALTERNATIVE THERAPY HE SUGGESTED. THE ALTERNATIVE TO THE INTERSTIM THERAPY WOULD BE A MAJOR SURGERY TO CREATE A STOMA IN WHICH TO CATHETERIZE MY BLADDER. I RETURNED FOR A DOCTOR'S VISIT ONE MONTH LATER. I WAS STILL HAVING PAIN, SO I DECIDED THAT I SHOULD HAVE THE INTERSTIM IMPLANT REMOVED. DURING THE SURGERY, THE LEAD WIRE BROKE INTO PIECES. THE DOCTOR MADE SURE TO TELL ME THAT HE'D GOTTEN ALL THE PIECES OUT. A HISTOLOGY REPORT DONE FOLLOWING THE SURGERY LISTED MY IMPLANT, WITH A DIFFERENT SERIAL NUMBER AND AN INTACT LEAD WIRE, RATHER THAN ONE THAT HAD BROKEN. THEN, I DECIDED TO GO WITH THE ALTERNATIVE THERAPY. THIS PROCEDURE HAS CREATED A STOMA IN WHICH TO CATHETERIZE MY BLADDER. IT'S CALLED A MITROFANOFF PROCEDURE. IT HAS BEEN A LIFE ALTERING PROCEDURE. AFTER ALL THIS, I CONTINUED TO HAVE PAIN. SO, I DECIDED TO HAVE SOME ADDITIONAL TESTING DONE. I WENT TO SEE A NEUROLOGIST AND HE DID NERVE CONDUCTION STUDIES AND AN EMG. HE WAS ABLE TO DETERMINE THAT I HAVE IRRITATION OF THE LEFT S1 (1ST SACRAL) NERVE ROOT AFTER THE REMOVAL OF A SACRAL NERVE STIMULATOR. HE SAID THAT THERE IS LEFT SIDED S1 RADICULOPATHY AND POSSIBLE ARACHNOIDITIS. HE ALSO SAID THERE WAS NERVE DAMAGE AT THE L5 LEVEL OF THE SPINAL CORD. SINCE THEN, I'VE HAD A SERIES OF NERVE BLOCKS TO TREAT THE PAIN. THESE HAVEN'T HELPED. I'VE BEEN PUT ON PAIN MEDICATIONS, NERVE MEDICATION AND MUSCLE RELAXANTS. ABOUT A YR LATER, I SAW AN ARTICLE IN THE NEWSPAPER REPORTING THAT THERE HAD BEEN LEAD FRACTURES ON A DEFIBRILLATOR THAT HAD BEEN MANUFACTURED BY THE SAME COMPANY. I TOOK A LOOK AT MY MEDICAL RECORDS AND THE DOCTOR HAD WRITTEN IN HIS CLINICAL NOTES THAT I HAD NOT ONLY ONE LEAD FRACTURE, BUT 2 OF THE LEADS HAD FRACTURED. I NOW HAVE TO LIVE WITH PERMANENT NERVE DAMAGE, LIFE ALTERING NEUROLOGICAL PROBLEMS AND PELVIC PAIN AT THE STIMULATION SITE THAT MAKES IT DIFFICULT FOR ME TO SIT FOR ANY LENGTH OF TIME. FRACTURED LEADS ON A SACRAL NERVE NEUROSTIMULATOR. THE LEAD WIRE CONNECTED TO A GENERATOR HAD FRACTURED. TWO OF THE FOUR LEADS HAD FRACTURED. THIS DEVICE IS ALSO CALLED AN INTERSTIM UNIT. RESULTS OF EVALUATION OF MEDICAL DEVICE: IMPEDANCE TEST RESULTS: IN 2006: DR'S CLINICAL NOTES STATE: "THE LEAD IN S2 AT ELECTRODE 3 DOESN'T SHOW ANY FUNCTION. THERE IS BORDERLINE FUNCTION OF THE SURROUNDING LEADS. THIS MAY REPRESENT A CRACK OR FRACTURE IN THE SYSTEM." ON 03/30/2006: DR'S NOTES FROM THIS VISIT STATE: "MOST RECENT INTERROGATION OF THE DEVICE SHOWS THAT 2 OF THE 4 LEADS ON THE ELECTRODE THROUGH THE S2 FOREMAN IS NO LONGER FUNCTIONING." ADDITIONALLY HE STATES "THE PT WITH COMPLEX VOIDING DYSFUNCTION, INTERSTIM DEVICE NOT WORKING PROPERLY. TWO OF THE FOUR ELECTRODES ARE FRACTURED. SHE STATES THAT SHE HAS PAIN RADIATING DOWN THE LEFT LEG AND LEFT SIDE."

    Description of Event or Problem · 1

    THE PRODUCT PROBLEM/EVENT WAS A LEAD WIRE FRACTURE ON AN INTERSTIM NEUROSTIMULATOR. THIS NEUROSTIMULATOR WAS USED AS SACRAL NERVE NEUROSTIMULATOR. I AM SUBMITTING THIS REPORT AS AN AMENDMENT TO A PREVIOUS REPORT. IT IS DATED 2008. I AM NOW ADDING THE LEAD NUMBER FOR THE LEAD WIRE THAT FRACTURED ON THIS SACRAL NERVE NEUROSTIMULATOR. THE LEAD WIRE ATTACHES TO THE INTERSTIM NEUROSTIMULATOR. THE UNIT CONSISTS OF AN INTERSTIM SACRAL NERVE NEUROSTIMULATOR, AN INTERSTIM TINED LEAD AND AN EXTENSION THAT CONNECTS THESE TWO PARTS. AGAIN, THE LEAD WIRE FRACTURED AND THE ENTIRE UNIT WAS EXPLANTED. ALSO, DURING THE EXPLANT PROCEDURE, THE LEAD BROKE INTO PIECES. THE PHYSICIAN TOLD ME THAT HE HAD REMOVED ALL THE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM TINED LEAD LEAD WIRE FOR INTERSTIM SACRAL NERVE NEUROSTIMULATOR LGW MEDTRONIC, INC. 3889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention