Description of Event or Problem · 1
HAD AN INTERSTIM NEUROSTIMULATOR FOR THE BLADDER PLACED IN 2003 FOR A NEUROGENIC BLADDER CAUSED FROM A SPINAL CORD COMPRESSION PRIOR TO SPINAL SURGERY IN 2002. DEVICE WORKED WELL, EXCEPT FOR OCCASIONAL SHOCK DOWN LEFT LEG, INTERMITTENT MOSTLY WITH ACTIVITY. IN (B)(6) 2006 HAD A SECOND SPINAL SURGERY IN SAME AREA OF SPINE-CERVICAL-, AFTER WHICH TIME IT WAS VERY DIFFICULT TO GET THE DEVICE TO WORK AFTER BEING TURNED OFF DURING A 2-1/2 HR SURGERY. NEITHER MY UROLOGIST OR HIS NURSE COULD GET MY DEVICE TO POWER UP. ALL THE WHILE I HAD TO KEEP A FOLEY CATH IN PLACE UNTIL THIS WAS RESOLVED. (B)(4) -MEDTRONIC REP- WAS CALLED TO MY ROOM TO RESOLVE. (B)(4) HAD BEEN MY PRIMARY MEDTRONIC REP/TEACHER SINCE PLACEMENT OF DEVICE IN 2003. (B)(4) WAS IN MY ROOM AT (B)(6) HOSPITAL (B)(6) FOR 4-5 HOURS TRYING TO RE-PROGRAM MY DEVICE. FINALLY AFTER SEVERAL TRIES HE WAS ABLE TO GET ENOUGH VOLTAGE TO ACTIVATE ONE LEAD TO PRODUCE ENOUGH STIMULATION FOR ME TO EMPTY MY BLADDER, BUT MADE IT VERY CLEAR ONLY 1 LEAD WAS WORKING. ALSO, HE TOLD ME WITH MY SON PRESENT THAT HIS BEST GUESS WAS THE OTHER LEADS WERE RENDERED "NON-FUNCTIONING" DURING SURGERY. HE STATED THIS HAPPENS ON OCCASION WHEN THE WIRES INTERACT WITH ELECTRO-CAUTERY, AND OTHER MACHINES IN THE OR. (B)(4) ALSO STATED THIS ONE LEAD WAS SUFFICIENT AS LONG AS IT FUNCTIONED AT CURRENT LEVEL. SO, FAST FORWARD TO 2008 - LATE IN THE YEAR, (B)(6)2008-(B)(6)2008. I BEGAN TO HAVE SYMPTOMS OF URGENCY, RETENTION RETURN, SOMETHING NOT EXPERIENCED SINCE 2003 PRIOR TO PLACEMENT OF INTERSTIM IN 2003. AFTER MULTIPLE CALLS TO MY THEN UROLOGIST, DR. (B)(6), WITH NO RESPONSE OR INADEQUATE RESPONSE, I CALLED (B)(4) WITH MEDTRONIC TO CHECK MY DEVICE. THE FOLLOWING DAY MEDTRONIC REP CAME TO MY PLACE OF EMPLOYMENT AND TESTED MY DEVICE REVEALING THE IMPEDANCE AS BEING BELOW CLINICAL PERFORMING, SO IN ESSENCE I HAD VERY LITTLE STIMULATION, WHICH WAS WHY I WAS HAVING THE SYMPTOMS I WAS. SO, AFTER MULTIPLE PHONE CALLS, AND PLEA'S FOR HELP I FOUND A NEW UROLOGIST WHO WAS READY AND WILLING TO HELP ME. HIS OFFICE CHECKED MY DEVICE AND CONCLUDED IT'S LACK OF FUNCTION, HE THEN -DR. (B)(6)- SCHEDULED A DEVICE CHANGE AND REPLACEMENT FOR (B)(6)2009. ON THE DAY OF SURGERY, DURING THE OPERATION, IT WAS DISCOVERED PER DR (B)(6) THAT NOT ONLY DID I HAVE JUST ONE FUNCTIONING LEAD, THAT LEAD WAS SO THIN IT FRACTURED IN HIS HAND WHEN HE TRIED TO REMOVE IT LEAVING A PIECE BEHIND. THIS EXTRA PIECE REQUIRED ANOTHER INCISION TO REMOVE THE OTHER PART OF THE LEAD THAT WAS LEFT BEHIND. PER HIS OPERATIVE NOTE HE SAID, "THE AREA IN AND AROUND THIS LEAD LOOKED LIKE A "TRAIN WRECK OF WIRES", AND NO WONDER NOTHING "FUNCTIONED". IMMEDIATELY AFTER REPLACEMENT AND ACTIVATION, MY VOIDING PATTERN RETURNED TO NORMAL, WITH ADEQUATE EMPTYING/WITHOUT RETENTION. PLEASE ALSO LET IT BE NOTED THAT MY LEFT LEG/FOOT REMAIN PERMANENTLY WEAK WITH PERSISTENT "FOOT DROP" LEFT FOOT. I HAVE KNOWN AND SPOKE WITH OTHER INDIVIDUALS THAT AFTER EXPERIENCING THESE "SHOCKS" DOWN ONE OR BOTH LEGS THEY HAVE STATED THEY TOO HAVE LASTING EFFECTS. DATES OF USE: (B)(6)2003 -- (B)(6)2009. DIAGNOSIS OR REASON FOR USE: NEUROGENIC BLADDER. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.