INTERSTIM II
Report
- Report Number
- 3004209178-2014-09311
- Event Type
- Injury
- Date Received
- May 20, 2014
- Report Date
- April 29, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCT: PRODUCT ID: 3889-28, LOT# VA0FUET, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION REPORTED THAT PATIENT STIMULATION WAS TURNING OFF. THE PATIENT REPORTED THAT STIM HAS BEEN SHUTTING OFF APPROXIMATELY 2 TIMES PER DAY. THE PATIENT REALIZED STIM WAS OFF BECAUSE SHE CHECKED WITH HER PROGRAMMER (PP) AND STIM WAS SHOWING OFF. IT WAS INDICATED THAT PATIENT HAD NOT HAD ANY REMARKABLE EMI EXPOSURES. NO CODES ON PP. IT WAS INDICATED THAT CALLER WAS GOING TO MEET WITH HEALTH CARE PROVIDER (HCP) LATER THIS AFTERNOON OF THE CALL. IT WAS INDICATED THAT THEY HAD CHANGED PROGRAMMING DURING LAST VISIT WITH PATIENT ON MAY 1 BUT THAT MADE STIM TURN OFF MORE FREQUENTLY. IT WAS LATER REPORTED THAT PATIENT WAS PROGRAMMED USING ELECTRODES 0 AND 1 AS WELL AS CASE AND 1 BUT THE ISSUE HAS PERSISTED THE PATIENT CONTINUED TO HAVE DEVICE TURN OFF MULTIPLE TIMES PER DAY. THE PATIENT WAS REPROGRAMMED TO 0-, 3+ ON (B)(6) AND DEVICE CONTINUES TO SHUT OFF. IT WAS INDICATED THAT THEY ARE PLANNING TO REPLACE THE GENERATOR AND SPEAKING WITH HCP ON THAT ISSUE ON THE DAY OF THE CALL. IT WAS LATER REPORTED THAT THERE WAS A POSSIBLE PRODUCT DEFECT / QUALITY ISSUE. THE PATIENT WAS MEETING WITH THE MANUFACTURER REPRESENTATIVE ON THE DAY OF THIS CALL DUE TO NEUROSTIMULATOR INS INTERMITTENTLY TURNING OFF. IT WAS NOTED THAT THEY CHANGED POLARITIES IN THE PAST; C/0 MADE IT HAPPEN MORE FREQUENTLY, 0/1 MADE IF HAPPEN MORE FREQUENTLY. THEY PROGRAMMED HER BACK TO 0-3+ THEY HAVE NOT TRIED C/1 BUT WAS TRYING THAT ON THE DAY OF THIS CALL AS WELL WITH PATIENT HAVING OPTION OF USING EITHER PROGRAM. THERAPY WAS 800 WITH THE 0-3+ OPTION IMPEDANCES TODAY C/0 734, C/1 1005, C/2 1005, C/3 1092, 0/1 1038, 0/2 1345, 0/3 2020, 1/2 1317, 1/3 2020, 2/3 2020. POSSIBLE FLUID SHORT WAS DISCUSSED, HOWEVER ALSO NOTED THAT SHOULD HAVE NO RELATIONSHIP WITH DEVICE TURNING ON AND OFF. THE PATIENT KNEW WHEN OFF SHE HAD RETURN OF SYMPTOMS, CHECKED DEVICE AND IT WAS OFF. THERE WERE NO INJURIES OR TESTING OR ANYTHING TO ACCOUNT FOR THIS. IT WAS NOTED THAT IT STARTED ABOUT ONE MONTH AFTER IMPLANT. IT WAS NOTED THAT THERE WAS AT NO TIME HAD ANY MASSAGES BEEN SE EN. INFORMATION RECEIVED LATER INDICATED THAT IMPEDANCES SEEMED FINE OR NOT THE PRIMARY ISSUE. IF ANY THERAPY CONCERNS THIS SHOULD BE LOOKED AT. INITIAL IMPEDANCES WERE TESTED AT THE DEFAULT PARAMETERS. IT WAS INDICATED THAT THE PRIMARY REASON WAS FOR THE STIM TURNING OFF. THE PATIENT WAS INADVERTENTLY TURNING IT OFF WHILE PRESSING THE SYNC BUTTON (PRESSING BOTH BUTTONS AT THE SAME TIME). IT WAS CONFIRMED THAT THE THERAPY WAS WORKING CORRECTLY, AND TRYING TO ADDRESS THE INS OFF ISSUE. IT WAS NOTED THAT PATIENT HAD OVERACTIVE BLADDER (OAB) AND URINATED UP TO 8-10 TIMES AN HOUR. WHEN PATIENT HAD TO URINATE SHE CHECKED DEVICE AND WAS FINDING THE INS WAS OFF. INFORMATION RECEIVED LATER INDICATED THAT PATIENT WAS BECOMING MORE AND MORE DISILLUSIONED BY THIS WHOLE ORDEAL AND PATIENT DID NOT WANT TO TURN IT BACK ON. THE PATIENT REPORTED THAT SHE WAS NOT TURNING THE DEVICE OFF ACCIDENTALLY AND WAS NOT MESSING WITH IT WHEN IT WAS WORKING. THE PATIENT NEVER CHANGED THE PROGRAM UNTIL ALL THIS STARTED. THE PATIENT INDICATED THAT SHE KNEW WHEN IT WAS ON AND OFF AND WAS READY TO HAVE THE DEVICE REMOVED. IT WAS INDICATED THAT PATIENT WAS "TIRED OF JUMPING THROUGH HOOPS". IT WAS NOTED THAT PATIENT'S SYMPTOMS HAD RETURNED AND THE WHOLE EXPERIENCE HAD ENDED VERY POORLY FOR PATIENT. THE PATIENT REPORTED THAT "SOMETHING WAS WRONG WITH THE UNIT SHE HAS". THE PATIENT WOULD MAKE ARRANGEMENTS TO HAVE THE LEADS AND GENERATOR REMOVED AND JUST CHALKS THIS UP TO A HORRIBLE EXPERIENCE.
IT WAS LATER INDICATED THAT PATIENT HAD A 50% OR GREATER SYMPTOM REDUCTION. IT WAS INDICATED THAT THE NEUROSTIMULATOR WAS INVOLVED IN THE REPORTED EVENT. THE DEVICE TURNED OFF BY ITSELF AFTER SEVERAL HOURS. THE DEVICE WAS REPROGRAMED 2 TIMES AND WAS ALSO INTERROGATED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS DETERMINED AND WAS DEVICE RELATED. IT WAS BELIEVED THAT THE DEVICE MALFUNCTIONS. IT WAS ALSO NOTED THAT WHEN WORKING, NEUROSTIMULATOR PATIENT HAD TERRIFIC RESPONSE. THE PATIENT OUTCOME WAS REPORTED AS NOT RECOVERED, SYMPTOM /ISSUE ONGOING.
IT WAS REPORTED THAT THERAPY WAS WORKING GREAT WHEN IT WAS ON BUT STIMULATION WAS TURNING OFF FOR NO REASON. IT WAS NOTED THAT THE PATIENT WOULD FEEL IT TURN OFF AND THEN CHECK THE DEVICE AND IT WOULD BE OFF WITH NO LIGHTNING BOLT. THE REPORTER STATED THAT THIS OCCURRED ABOUT TWO TIMES A DAY AND THE PROBLEM STARTED ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT SOMETIMES NEEDED TO TURN UP THE AMPLITUDE AFTER TURNING THE IMPLANTABLE NEUROSTIMULATOR (INS) BACK ON. THE NORMAL AMPLITUDE WAS 1.8 VOLTS AND THE PATIENT TURNED IT UP TO 4 VOLTS. IT WAS NOTED THAT THE PROGRAMS USED BY THE PATIENT WERE 0 NEGATIVE, 3 POSITIVE AND 1 NEGATIVE, 3 POSITIVE. THE IMPEDANCES WERE AS FOLLOWS: CASE AND 0 ¿ 616, CASE AND 1 ¿ 736, CASE AND 2 ¿ 1111, CASE AND 3 ¿ 1111, 0 AND 1 ¿ 1111, 0 AND 2 ¿ 1147, 0 AND 3 ¿ 1226, 1 AND 2 ¿ 1111, 1 AND 3 ¿ 1226, 2 AND 3 ¿ 1185. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION REPORTED LATER INDICATED THAT THERE WAS NO REPLACEMENT DATE AS OF YET. THE PATIENT CONTINUED TO REPORT THE DEVICE INTERMITTENTLY SHUTTING OFF MULTIPLE TIMES DAILY. SHE ALSO REPORTED A SUDDEN INCREASE IN STIMULATION OF OVER 1 FULL VOLT, DESPITE THE FACT THAT SHE WAS NOT IN POSSESSION OF HER PROGRAMMER AT THE TIME. SHE WAS QUITE FRUSTRATED. THE MANUFACTURER REPRESENTATIVE INDICATED THAT SOMETHING WAS NOT RIGHT WITH HER GENERATOR AND THOUGHT REPLACEMENT SHOULD BE APPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300227 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |