INTERSTIM II
Report
- Report Number
- 3004209178-2013-08380
- Event Type
- Injury
- Date Received
- May 30, 2013
- Date of Event
- April 9, 2012
- Report Date
- September 20, 2019
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 3093-28, LOT# V811041, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PT M_PROG, PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4)
(B)(4).
(B)(4).
DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. PATIENT CODE (B)(4) WAS OMITTED FROM PRIOR REPORTS AND HAS BEEN ADDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID 3093-28, LOT# V811041, IMPLANTED: (B)(6) 2012. PRODUCT TYPE LEAD .PATIENT CODE(B)(4) APPLIES TO INTERSTIM (SERIAL#(B)(4)) AND LEAD (LOT# V811041). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT OVER THE LAST ¿FEW MONTHS,¿ SINCE (B)(6) 2012, THE PATIENT HAD TO REVISIT HER IMPLANTING HEALTH CARE PROVIDER (HCP) FOR ADJUSTMENTS AND REPROGRAMMING BECAUSE SHE HAD TWO TO THREE INCIDENTS OF DIARRHEA AND FECAL INCONTINENCE. AFTER THE PATIENT¿S MOST RECENT ADJUSTMENT, ¿THINGS¿ WERE GOING GOOD UNTIL THE WEEK PRIOR TO THE REPORT. FOR FIVE STRAIGHT DAYS, THE PATIENT HAD EXTREME DIARRHEA, THREW UP, AND SICKNESS. THE PATIENT WAS ¿VERY ILL¿ AND TOOK ANTIBIOTICS AND ¿IMMODIUM.¿ AS OF THE NIGHT OF (B)(6) 2013, THE PATIENT CONTINUED TO HAVE DIARRHEA ALL NIGHT AND INCONTINENCE EPISODES FIVE TO SIX TIMES A NIGHT. IT WAS ¿SO MUCH¿ THAT THE PATIENT WAS UNABLE TO ¿LEAVE HER HOUSE, SHE SOILED ALL OF THE LINENS, AND SHE LEFT A TRAIL FROM THE COUCH TO THE BATHROOM THAT SHE HAD TO CLEAN UP.¿ THE PATIENT HAD NOT SEEN A HCP SINCE THESE SYMPTOMS BEGAN AND WAS SUPPOSED TO SEE ONE THE DAY OF THE REPORT BUT DID NOT BECAUSE SHE ¿WAS UNABLE TO LEAVE.¿ THE PATIENT WOULD NOT LEAVE HER HOUSE BECAUSE OF HER CONDITION. THE PATIENT DID NOT FEEL STIMULATION AT THE TIME OF THE REPORT AND ¿USUALLY¿ DID WHEN SHE WAS PROGRAMMED FOR A ¿LITTLE WHILE¿ BUT THEN IT WENT AWAY. THE DEVICE WAS CONFIRMED TO BE ON AND THE PATIENT WAS ASSISTED IN ADJUSTING UP TO 2.8 VOLTS. THE PATIENT ¿THOUGHT SHE WAS ABLE TO FEEL STIMULATION¿ AT THIS SETTING. THE PATIENT ALSO STATED THAT SHE HAD PHYSICAL THERAPY OVER THE ¿LAST SEVERAL MONTHS¿ THAT INVOLVED BODY MANIPULATION. IT WAS STATED THAT THE PATIENT HAD ¿EXTREME¿ PAIN DURING PHYSICAL THERAPY THAT CAUSED HER TO CRY. IT WAS NOTED THAT THE PAIN WAS IN THE SAME AREA AS THE PATIENT'S SPINAL FUSION SURGERY AND THIS SURGERY WAS WHAT CAUSED HER TO HAVE FECAL INCONTINENCE. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
IT WAS REPORTED X-RAYS SHOWED THAT EVERYTHING WAS CONNECTED. STIMULATION WAS HELPING CONTROL THE PATIENT'S DIARRHEA, BUT THEY STILL HAD TO TAKE MEDICATION.
IT WAS REPORTED THE PATIENT HAD DIARRHEA THE MORNING OF THE CALL. THE PATIENT HAD AN UNRELATED SURGERY A WEEK PRIOR TO CALL AND WANTED TO CHECK IF THE STIMULATOR WAS TURNED BACK ON. THEY DID NOT HAVE THEIR PROGRAMMER WITH THEM.
IT WAS REPORTED THAT THE PROGRAMMER TRAINING WAS INEFFECTIVE BECAUSE THE PATIENT WAS STILL UNDER THE EFFECTS OF ANESTHESIA AND THE PATIENT LACKED BASIC UNDERSTANDING OF PATIENT PROGRAMMER USE. IT WAS REPORTED THAT THE PATIENT THOUGHT THE BATTERY IN THEIR PROGRAMMER WAS DEAD AND PUT IN NEW BATTERIES. THE PATIENT COULDN'T GET ANYTHING TO HAPPEN WHEN THEY TRIED TO TURN IT ON AND COULDN'T GET THE LIGHT TO COME BACK ON. AFTER CHANGING THE BATTERIES AGAIN, THE PATIENT WAS ABLE TO TURN THEIR PROGRAMMER ON. THE PATIENT HAD A CIRCLE WITH AN EXCLAMATION POINT ON THE SCREEN OF THEIR PROGRAMMER. IT WAS REPORTED THAT THE PATIENT WAS HAVING A HORRIBLE FEELING AND WAS WONDERING IF SOMETHING COULD HAVE BEEN DAMAGED DURING PHYSICAL THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOT OF NECK PROBLEMS AND WANTED TO USE A TENS UNIT FOR THEM.
IT WAS LATER REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND WAS EXPERIENCING A LOT OF PROBLEMS, SPECIFICALLY UNCONTROLLED DIARRHEA. IT WAS STATED THE PATIENT'S RETURN OF SYMPTOMS BEGAN IN (B)(6) 2012 AND THEY COULD HARDLY GET OUT OF THE HOUSE BECAUSE THEIR SYMPTOMS WERE SO BAD. IT WAS NOTED THE PATIENT HAD DONE "TESTS <(>&<)> TESTS" AND THE TESTS SHOWED THE "BATTERIES <(>&<)> EVERYTHING ARE GOOD." THE PATIENT STATED THEY HAD IMAGING DONE A FEW MONTHS AGO AND ALSO A YEAR POST-OPERATIVE. THE PATIENT NOTED "IT" HAS MOVED SOME BECAUSE THEY GAINED A LOT OF WEIGHT DURING RECOVERY FROM BACK SURGERY AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SURGERY BUT AT THE TIME OF REPORT THEY HAD LOST A LOT OF WEIGHT. THE PATIENT CLARIFIED THE INS HAD MOVED SOME BUT THE LEAD WIRES WERE STILL IN PLACE. IT WAS STATED REPROGRAMMING WAS DONE AND THEY TRIED TO INCREASE THE VOLTAGE BUT THE INCREASE IN VOLTAGE CAUSED A BURNING AND ITCHING SENSATION IN THE VAGINAL AREA SO THE STIMULATION WAS SET AT A LOWER COMFORTABLE LEVEL. THE PATIENT STATED THEIR MEDICATION WAS BEING ADJUSTED AND THE TESTS WERE STILL ONGOING. IT WAS NOTED THE PATIENT'S PHYSICAL THERAPY WAS ALSO ONGOING AND OFF AND ON DEPENDING ON SYMPTOMS. REPORTEDLY, PRIOR TO (B)(6) 2012, THE INS WAS CONTROLLING THEIR FECAL INCONTINENCE AND THEY FELT THE URGE TO GO BUT AT THE TIME OF REPORT THEY WEREN'T AWARE THEY WERE GOING WHILE SLEEPING AND EVEN WHEN THEY WERE AWAKE THEY WERE "GUSHING THROUGH" WITH DIARRHEA AND COULD NOT MAKE IT TO THE BATHROOM ON TIME.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. THE PATIENT REPORTED THEY WERE STILL HAVING OCCASIONAL BOWEL ISSUES. THE PATIENT ALSO REPORTED HAVING DIARRHEA AND THAT THEY COULD NOT GO 2-3 DAYS WITHOUT HAVING THIS ISSUE. THE PATIENT ALSO NOTED THEY HAVE BEEN SICK TOO MUCH. THE PATIENT WAS RE-DIRECTED TO FOLLOW UP WITH THEIR HEALTH CARE PHYSICIAN (HCP) TO DISCUSS THEIR SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT WHO NOTED THE PATIENT PROGRAMMER (PP) WOULDN'T CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THEY ADDED THAT THEY HAD A COLONOSCOPY AND ENDOSCOPY A WEEK PRIOR TO THE REPORT AND WAS UNABLE TO TURN THERAPY OFF. THE PATIENT HAD THEIR PP AND ANTENNA AT TIME OF THE CALL; IT WAS CONFIRMED THAT THE ANTENNA WAS SECURE. AN ATTEMPT WAS MADE TO SYNC TO THE INS, BUT THE POOR COMMUNICATION ISSUE WAS NOT RESOLVED. THE ANTENNA WAS THEN REMOVED FROM THE PP AND THE PP WAS PLACED DIRECTLY OVER THE INS ON THE SKIN. AN ATTEMPT WAS MADE TO SYNC TO THE INS, BUT THE POOR COMMUNICATION ISSUE WAS NOT RESOLVED. THE CALL CENTER CONSIDERED THE INS LONGEVITY RELATIVE TO DATE OF IMPLANT SO THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER (HCP). DURING THE CALL, PATIENT ALSO SAID THEY ARE HAVING RETURN OF SYMPTOMS AND THEY'VE BEEN EXPERIENCING OTHER MEDICAL ISSUES FOR AWHILE NOW. THEY NOTED HAVING BACK SURGERY, LOSING WEIGHT, GAINING WEIGHT, THEIR BODY CHANGING, AND THE INS MOVING SOME; THEY ARE NOT SURE IF THAT HAPPENED AGAIN. DURING TROUBLESHOOTING, CONSUMER SAID THEY CAN PLACE THEIR FINGER ON THE LEAD BECAUSE IT BULGES OUT. PATIENT NOTED THAT THEY HAVE AN APPOINTMENT NEXT WEEK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240170 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |