INTERSTIM II
Report
- Report Number
- 3004209178-2014-13635
- Event Type
- Injury
- Date Received
- July 29, 2014
- Date of Event
- June 27, 2014
- Report Date
- July 9, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0JYXY, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# VA0JYXY, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALIES. THE CONNECTOR MODULE AND CAN WERE SCRATCHED. THE INS FUNCTIONED PROPERLY THROUGHOUT THE DURATION OF THE TEST. ANALYSIS OF THE LEAD FOUND NO SIGNIFICANT ANOMALIES. THE LEAD BODY WAS CUT THROUGH AND PRODUCT WAS SEGMENTED, AND CONDUCTORS WERE CUT. THIS IS NOT UNEXPECTED AS THE LEAD WAS CUT OFF WHEN EXPLANTED. THE LEAD FUNCTIONED PROPERLY THROUGHOUT THE DURATION OF THE TEST. (B)(4).
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE WIRES WERE RIGHT UNDER THE SKIN AS THE PATIENT WAS VERY THIN AND DIDN¿T HAVE MUCH FAT AND THE LEAD WAS VISIBLE. IT WAS NOTED THAT THE PATIENT WOULD TALK TO THEIR HEALTH CARE PROVIDER (HCP) TOMORROW ABOUT IT. WHEN THE PATIENT WENT FROM 0.80V TO 0.90V THEY GOT ZAPPED OR FELT A JOLT. IT WAS REPORTED THAT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) THE PATIENT WAS NOT NOTICING A DIFFERENCE IN SYMPTOM RELIEF AND THE SYMPTOMS HAPPENED EARLY IN THE MORNING AND AFTER THEY ATE AND THE PATIENT WAS ONLY TURNING ON THE STIMULATION DURING THOSE TIMES. IT WAS NOTED THAT THE PATIENT HAD ANAL SURGERY AND IT TOTALLY DAMAGED THEIR ANAL SPHINCTER AND IT WAS RIPPED AND SHREDDED. THE PATIENT¿S HCP GAVE THEM A BLOCKING AGENT AND THEY HAD A HARD TIME GOING TO THE BATHROOM AND THEY ¿PUSHED UNTIL THEIR HEAD CAME OFF.¿ IT WAS REPORTED THAT THEY DID AN ULTRASOUND AND IT SHOWED BLACK IN THE BLADDER AREA. THE PATIENT¿S HCP TOLD THEM TO KEEP IT ON ALL THE TIME AND THE PATIENT DIDN¿T FEEL THEY NEEDED TO TURN IT ON ALL THE TIME. IT WAS STATED THAT THE PATIENT HAD IT ON ALL THE TIME AND IT STILL WASN¿T HELPING WITH THEIR SYMPTOMS. THE PATIENT WAS ALSO GETTING CANCER AND THEY NEEDED TO GET AN MRI BUT THEIR HCP TOLD THEM TO DO A CT SCAN DUE TO THE INS. IT WAS NOTED THAT THE PATIENT WAS THINKING ABOUT GETTING THE INS TAKEN OUT AND WANTED TO TALK TO SOMEONE OTHER THAN THEIR HCP AND THEIR MANUFACTURER REPRESENTATIVE.
IT WAS REPORTED THE PATIENT¿S STIMULATOR WAS REMOVED. THE LEADS WERE CUT OFF. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS REPORTED THE PATIENT HAD NERVE DAMAGE FROM THE IMPLANT PROCEDURE. THE PATIENT KNEW THE IMPLANT DOCTOR CUT NERVES. THE DOCTOR SAID THE PATIENT HAD ¿NO FLESH.¿ THE PATIENT ALSO EXPERIENCED SACRUM PAIN.
IT WAS REPORTED THAT NINE DAYS AFTER THE FIRST SHOCK, THE PATIENT TURNED THE STIMULATOR BACK ON AND GOT SHOCKED. THE STIMULATOR HAD BEEN OFF SINCE THEN.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT SINCE IMPLANT, THE DEVICE HAD NOT BEEN EFFECTIVE. IN (B)(6) 2015, THE PATIENT REPORTEDLY ¿COULD NOT WALK¿ DUE TO PAIN IN THEIR BUTTOCKS. MUSCLES WERE TIRED AND IN PAIN. ADDITIONALLY, THE PATIENT WAS NUMB FROM THE IMPLANT SITE OVER TO HIS SPINE DOWN TO HIS COCCYX ¿IN A PIE SHAPE.¿ THE DEVICE WAS REMOVED IN MARCH, BUT THE PATIENT WAS STILL HAVING BUTTOCK PAIN EVERY DAY.
LATER THE PATIENT CALLED ABOUT THE SAME ISSUE HE HAD CALLED IN ABOUT PREVIOUSLY. HE WANTED TO KNOW THE RESULTS OF THE ANALYSIS OF HIS EXPLANTED INS. THE PATIENT ALSO REPORTS IN HIS CALL THAT HE EXPERIENCED EXTREME PAIN FROM THE STIMULATOR AND HIS IMPLANTING PHYSICIAN TOLD HIM THAT HE WILL LIKELY ALWAYS HAVE PAIN THERE. THE PATIENT REPORTS HE CONTINUES TO HAVE PAIN AND CANNOT WALK HALF A BLOCK WITHOUT EXTREME PAIN AND HAD TO STOP AND TAKE A BREAK.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS LOOKING AT THE PROGRAMMER AND HAD A QUESTION ABOUT ONE OF THE SCREENS THEY WERE NAVIGATING TO. THE PATIENT WANTED TO KNOW HOW MUCH SPHINCTER DAMAGE HAD TO HAVE OCCURRED BEFORE THE STIMULATION DIDN¿T WORK. IT WAS NOTED THAT THE DEVICE WAS NOT HELPING WITH THE PATIENT¿S SYMPTOMS. THE PATIENT HAD DONE THEIR OWN OBJECTIVE STUDY WHERE THEIR BOWEL MOVEMENTS WERE THE SAME WITH STIMULATION ON AND OFF. IT WAS STATED THAT THE BOWEL MOVEMENTS ONLY CAME IN THE MORNING AND WITH STIMULATION ON THEY HAD 30 SECONDS TO A MINUTE TO GET TO THE BATHROOM BEFORE AN ACCIDENT AND THAT WAS THE SAME WITH STIMULATION OFF. WITH STIMULATION ON THE PATIENT SOMETIMES WENT TWICE A DAY AND WITH STIMULATION OFF THEY WENT 1 MAYBE 2 TIMES A DAY. IT WAS REPORTED THAT THE PATIENT¿S INDICATION WAS INCONTINENCE DUE TO SPHINCTER DAMAGE DUE TO AN ANAL STENOTIC ABLATION. IF THE PATIENT TURNED STIMULATION UP ON THE PROGRAMS IT WAS UNCOMFORTABLE. IT WAS NOTED THAT ON GROUP 2 THE PATIENT FELT STIMULATION IN THE WRONG AREA AND IT CAUSED PAIN. THE STIMULATION ONLY AFFECTED THE RIGHT SIDE OF THE PATIENT¿S BODY. IT WAS STATED THAT THE PATIENT DID NOT KNOW THE EXTENT OF THE DAMAGE TO THEIR ANUS AND THEY HAD A 2 WEEK TRIAL AND IT WAS NOT HELPFUL FOR THEIR SYMPTOMS. THEY STILL MOVED FORWARD WITH THE THERAPY AND THE PATIENT HAD STIMULATION ON AND HAD TO GO IN THE MIDDLE OF THE NIGHT AND THIS WAS A NEW EXPERIENCE FOR THEM. THE PATIENT WOULD LIKELY HAVE THE DEVICE REMOVED DUE TO BEING EXHAUSTED MENTALLY AND PHYSICALLY.
IT WAS REPORTED THE PATIENT WAS IN PAIN AND COULD NOT WALK WITH STIMULATION OFF. THE PATIENT ALSO EXPERIENCED A BURNING SENSATION FROM THE PAIN IN THEIR LEFT BUTTOCKS. THEIR STIMULATOR WAS "KILLING THEM" AFTER STRENUOUS WALKING. WALKING HALF A BLOCK MADE THEIR WHOLE LEFT SIDE HURT. STIMULATION HAD BEEN OFF FOR OVER FOUR MONTHS. TWO WEEKS AFTER IMPLANT, THE PATIENT WANTED TO RIP THE STIMULATOR OUT WHEN THE PAIN MEDICATION WORE OFF. THE STIMULATOR NEVER WORKED PROPERLY. THE PATIENT'S ANUS WAS NUMB SINCE IMPLANT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS LATER REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT WENT THROUGH THE TRIAL IN (B)(6) AND IT WAS ¿50-50.¿ THE PATIENT STATED THAT THEY WERE STILL 50-50 AFTER IMPLANT WEATHER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON OR OFF. THEY DECIDED TO KEEP THE INS IN AND THE PATIENT WENT THROUGH THE FIRST SET OF PROGRAMS AND IT WAS 50-50. THE PATIENT STATED THAT THE DOCTOR TOLD THEM TO KEEP THE INS ON ALL THE TIME BUT THE BOOK TOLD THEM NOT TO. THE PATIENT WOULD GENERALLY LEAVE IT OFF AT HOME. THE PATIENT WOULD NORMALLY TURN THE INS OFF AT NIGHT BUT THEY DIDN'T A COUPLE WEEKS PRIOR TO REPORT. THAT NIGHT, AT 3 AM THE PATIENT GOT A SHOCK IN HIS BACK AND RECTUM AND STATED "THAT DROVE MY CRAZY." THE PATIENT STATED IT CAUSED HIS BACK AND RECTUM TO SPASM AND THEY TURNED THE INS OFF. THE PATIENT CALLED THEIR DOCTOR AND THEY DIDN¿T KNOW WHY THAT HAPPENED. THE MONTH PRIOR TO REPORT THE PATIENT WENT IN FOR ANOTHER SET OF 4 PROGRAMS AND PROGRAMS 1 AND 2 WOULD ¿ACTIVATE HIS PENIS¿ AND HE DIDN¿T LIKE THAT. THE PATIENT TRIED PROGRAM 4 AT 0.5 VOLTS AND WAS ON THAT FOR THE DAY. THE PATIENT WAS TOLD TO ¿FLUSH HIMSELF EVERY MORNING¿ AND USE ¿LO-MOTIVE¿ WHEN NEEDED AND THE PATIENT STILL DID THIS WHETHER THE INS WAS ON OR OFF. THE PATIENT ALSO NOTED THAT HE HAD NO FLESH IN HIS BACK SO THE INS HURT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441268 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Other| R |