INTERSTIM II
Report
- Report Number
- 3004209178-2013-04527
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Report Date
- March 13, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3093-33 LOT# V851923, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, AND WAS STILL LEAKING AND WEARING PADS. THE PATIENT GOT RESULTS THE FIRST FEW MONTHS BUT HAD REVERTED BACK TO HER "ORIGINAL CONDITION". THE REPORTER INDICATED THAT THE PATIENT HAD HER DEVICE UP TO 2.2V IN THE PAST BUT WHEN SHE HAD IT AT ANY LEVEL HIGHER THAN THAT, EVEN AT 2.3V, SHE GOT A "SHOCK WAVE". THE REPORTER STATED THAT THE PATIENT DIDN'T REALLY USE HER PROGRAMMER AT ALL AND COULDN'T RECALL MAKING ANY ADJUSTMENTS. HOWEVER, THE PATIENT HAD BEEN "TINKERING" WITH THE PROGRAMMER AND MAY HAVE BEEN ON PROGRAM 2 BEFORE. THE REPORTER ALSO STATED THAT THE PATIENT TRIED TO HAVE AN EKG DONE RECENTLY BUT WASN'T ABLE TO COMPLETE THE DIAGNOSTIC PROCEDURE AS THE DEVICE WAS ON AND WAS PROVIDING INTERFERENCE. THE PATIENT WAS GOING TO REPEAT THE PROCEDURE BUT WITH HER DEVICE OFF. IT WAS NOTED THAT THE PATIENT HADN'T BEEN FOLLOWING UP WITH HER HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BUT WAS WORKING WITH THEIR DOCTOR TO RESOLVE THE ISSUE. AN APPOINTMENT OF (B)(6) 2013 WAS NOTED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION, LOSS OF THERAPEUTIC EFFECT, AND STIMULATION IN THE WRONG LOCATION. IT WAS STATED THAT 4 MONTHS POST IMPLANT; THE PATIENT WENT ON A TRIP AND STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NO LONGER EFFECTIVE. THE PATIENT TRIED TO INCREASE STIMULATION, BUT ¿IT WAS NOT WORKING.¿ THE PATIENT REPORTEDLY TURNED THE INS OFF PRIOR TO BOARDING AN AIRPLANE. THE PATIENT FELT STIMULATION BEFORE TURNING THE INS OFF. THE PATIENT GOT BACK FROM THE TRIP IN (B)(6) 2013 AND WAS UNABLE TO TURN STIMULATION BACK ON. THE PATIENT ADDED THAT THE AMPLITUDE WAS AT ¿2, BUT SHE COULD NOT FEEL THE STIMULATION AND 3 WAS PUSHING IT.¿ THE PATIENT COMPLAINED OF WORSENING SYMPTOMS OVER THE PAST 6 MONTHS, ¿AROUND THE TIME SHE TURNED IT OFF.¿ IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT ADEQUATELY TRAINED ON THE USE OF THE INS. THE PATIENT WAS TO FOLLOW UP WITH HER DOCTOR TODAY. IT WAS STATED THAT THE PATIENT HAD TROUBLE USING THE PROGRAMMER AND IT TOOK A WHILE TO ESTABLISH COMMUNICATION. THE PATIENT REPORTEDLY CONSIDERED THE LEFT SIDE OF THE SCREEN ¿THE RIGHT SIDE¿ AND VICE VERSA, SO TROUBLESHOOTING WAS DIFFICULT. THE PATIENT WAS EVENTUALLY ABLE TO TURN THE INS ON AND SEE THE LIGHTNING BOLT. THE PATIENT WAS ON PROGRAM 4 AT 0.7 VOLTS. THE PATIENT INCREASED STIMULATION UP TO 1.5 VOLTS AND REPORTED FEELING ¿CONSTANT STIMULATION.¿ HOWEVER, IT WAS LATER STATED THE PATIENT LOOKED AGAIN AND WAS UNSURE IF THE LIGHTNING BOLT WAS THERE. THE PATIENT WAS CONFUSED AND WAS UNSURE IF THE INS WAS ACTUALLY ON OR OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136096 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |