INTERSTIM II
Report
- Report Number
- 3004209178-2013-07252
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Report Date
- April 16, 2013
- 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V840296, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# V840296, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V840296, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# V840296, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED AN UNSPECIFIED DIAGNOSTIC TEST ON (B)(6) 2013 SHOWED THE ¿TIP OF THE STIMULATOR¿ LIED IN THE REGION OF THE PATIENT¿S RECTUM. REPROGRAMMING WAS PERFORMED ON (B)(6) 2013 TO SATISFACTION. HOWEVER, THE PATIENT HAD NO RELIEF AND HER SYMPTOMS OF URGENCY, FREQUENCY, AND LEAKAGE PERSISTED. OTHER ASSOCIATED SIGNS AND SYMPTOMS WERE OVERACTIVE BLADDER AND NOCTURIA. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY. FIVE DAYS LATER IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY BUT SHE HAD SOUGHT FURTHER HELP. THE PATIENT FELL IN (B)(6) 2011 AND DID NOT REALIZE AT FIRST THAT ANYTHING HAD HAPPENED. A FEW WEEKS AFTER THIS FALL THE PATIENT REALIZED THAT IT WAS ¿NO LONGER WORKING¿ AND IT HAD TURNED ITSELF OFF. THE PATIENT TURNED THE DEVICE BACK ON BUT IT WAS NOT WORKING LIKE IT DID BEFORE. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) TRIED TO ¿RETUNE¿ THE DEVICE BUT IT ¿ONLY¿ WORKED ON TWO OF THE ¿CHANNELS¿ AND AT A ¿REDUCED LEVEL.¿ THE PATIENT HAD AN X-RAY AND IT WAS DETERMINED THAT THE DEVICE HAD MOVED. AROUND THE TIME OF THE REPORT THE DEVICE TURNED ITSELF ON AND OFF ¿SOMETIMES¿ AND ¿SOMETIMES WORKED PRETTY GOOD.¿ HOWEVER, ¿SOMETIMES¿ THE PATIENT WAS ¿WET ALL THE TIME.¿ THE PATIENT WAS ¿JUST IN¿ THE HOSPITAL FOR AN UNRELATED KNEE SURGERY AND SHE ¿JUST MOVED AND WAS CONSTANTLY WET.¿ THE PATIENT DECIDED TO TURN THE DEVICE OFF BECAUSE IT WAS NOT WORKING BUT TURNED IT BACK ON AFTER TALKING TO A MANUFACTURE REPRESENTATIVE. AT THE TIME OF THE REPORT THE DEVICE WAS WORKING ¿BETTER THAN IT EVER DID.¿
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. ABOUT ONE WEEK OR SO AFTER A FALL, THE PATIENT NOTED THAT STIMULATION WASN'T WORKING AS WELL. THE DEVICE WAS REPROGRAMMED AT THAT POINT AND NO OTHER CONCERNS WERE MENTIONED AT THAT TIME. IT HAD BEEN "GOING DOWN HILL SINCE THEN." THE PATIENT HAD X-RAYS AT SOME POINT AND WAS TOLD THAT THE WIRE MOVED AND THERE WAS ONLY ONE GOOD ELECTRODE. THE PATIENT WAS LAST REPROGRAMMED ABOUT 2 MONTHS AGO OR SO BUT SHE WAS NOW EXPERIENCING A COMPLETE RETURN OF SYMPTOMS, NOT JUST LEAKING ANYMORE, INCONTINENCE. LAST WEEK "IT STOPPED WORKING AT ALL." THE PATIENT WAS CURRENTLY IN HOSPITAL DUE TO KNEE REPLACEMENT SURGERY. IT WAS NOTED THAT STIMULATION WAS TURNING OFF. THERE WAS AN OVERSTIMULATION SENSATION. IN (B)(6) 2012 THE PATIENT FELL OUT OF A TRUCK BED (PATIENT WAS STANDING) AND FELL ON HER BACKSIDE. THE PATIENT COULD NOW READILY SEE THE NEUROSTIMULATOR AND IT WAS MOVING AROUND QUITE A BIT. THE PATIENT HAD BEEN WORKING WITH CURRENT PHYSICIAN HOWEVER ALL THAT HAS BEEN DONE SO FAR HAS NOT BEEN HELPFUL IN REGAINING SYMPTOM CONTROL. STIM WAS CURRENTLY OFF ON PROGRAM 4 @ 1.7V. THE PATIENT WAS ABLE TO SUCCESSFULLY TURN STIMULATION ON BUT SAID THAT SHE DIDN'T FEEL STIMULATION. THE PATIENT TYPICALLY RECEIVED BETTER SYMPTOM CONTROL IF SHE HAD STIMULATION SET SO IT WAS ONE LEVEL LOWER THAN WHEN SHE FELT STIMULATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS REPORTED THAT THE PATIENT COULD FEEL WHERE THEIR NEUROSTIMULATOR WAS AND BEFORE THEY COULDN'T FEEL IT. THE PATIENT COULD NOT TURN ON THEIR DEVICE ANYMORE.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT WAS HAVING AN MRI FOR HER LUMBAR BACK SHE HAD PAIN DOWN HER LEGS AND DID NOT THINK IT WAS HER STIMULATOR. THE PATIENT ALSO MENTIONED THAT THE HEALTH CARE PROVIDERS DID NOT THINK IT WAS RELATED. THE PATIENT INDICATED THAT THE PAIN GOING DOWN HER RIGHT LEG HAD BEEN GOING ON FOR ABOUT A YEAR. IT WAS ALSO NOTED THAT THE PAIN ALSO CAME TO THE LEFT SIDE ACROSS HER GROIN AND THE STIMULATOR WAS NOT NEAR THE PAIN BUT WAS HIGHER UP IN HER LEFT HIP. THE PATIENT WAS NOT SURE IF THE PAIN WAS A GRADUAL OR SUDDEN ONSET. IT WAS REPORTED THAT PATIENT HAD A KNEE REPLACEMENT ON HER RIGHT LEG (B)(6) 2013 AND SHE WAS ALLERGIC TO PAIN MEDICATIONS. WHEN SHE STOPPED THE PAIN MEDICATION SHE DID NOT HAVE THE PAIN ANYMORE. THE PATIENT STATED ABOUT 6 MONTHS OR SO LATER STARTED GETTING PAIN AND IT STARTED GOING DOWN HER LEG AND HAD NO IDEA WHAT IT WAS. THE PATIENT TALKED TO HER (PRIMARY CARE PHYSICIAN) ABOUT IT AND FINALLY WENT TO ANOTHER HCP. THE PATIENT DID NOT KNOW WHAT WAS WRONG WITH HER BACK BECAUSE IT KEPT ON HURTING HER. THE PATIENT HAD NOT ANY FALLS OR TRAUMA IN THE LAST YEAR. IT WAS ALSO MENTIONED THAT AFTER PATIENT FALL SHORTLY AFTER IMPLANT THE STIMULATOR WORKED ON ONE SETTING AT ONE SPEED AND THAT WAS THE ONLY ONE SETTING USED. IT WAS NOTED THAT AFTER THAT FALL THE MANUFACTURER REPRESENTATIVE CAME IN A FEW TIMES TO REPROGRAM AND COULDN'T GET THE STIMULATION ON ANY OTHER SETTING THEN WHAT PATIENT HAD NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194295 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |