INTERSTIM II
Report
- Report Number
- 3004209178-2013-00138
- Event Type
- Injury
- Date Received
- January 4, 2013
- Report Date
- December 12, 2012
- 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
PRODUCT ID 3093-33, LOT # V871805, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT HAD THE INITIAL SURGERY IN MARCH AND "IT WASN'T RIGHT" SO SHE UNDERWENT ANOTHER SURGERY IN SEPTEMBER. HOWEVER, THE DEVICE HAD NEVER WORKED. THE REPORTER INDICATED THAT THE PATIENT HAD TRIED ALL 4 PROGRAMS AND THEY WORKED FOR A LITTLE WHILE THEN STOPPED WORKING. THE PATIENT WAS NOTED TO HAVE BEEN USING 3 PADS AND HAD 2 PADS AND TOWELS ON THE BED. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 2 WEEKS LATER INDICATED THAT THE CAUSE OF THE EVENT WAS LEAD MIGRATION. THERE WAS AN M RI/X-RAY/CT SCAN IN (B)(6) 2012 AND THE RESULTS WERE NOTED AS PROXIMAL LEAD. SURGICAL REVISION OF THE LEAD OCCURRED TWO MONTHS AFTER THE SCAN WAS DONE. HOWEVER, THERE HAD BEEN NO IMPROVEMENT YET. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO PATIENT INJURY.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DISSATISFIED WITH HER DEVICE BECAUSE SHE CHANGED PROGRAMS AND THEY WOULD ONLY WORK FOR 'A LITTLE BIT' AND THEN THEY WOULD NOT WORK ANYMORE. THE PATIENT SPOKE WITH HER HEALTH CARE PROVIDER (HCP) AND THEY ASK HER TO COME IN FOR A REPROGRAMMING. IT WAS STATED THAT THIS WAS THE PATIENT'S 'SECOND SET OF PROGRAMS.' IT WAS ALSO STATED THAT THE PATIENT GOT 'THE POSITION OF THE SENSORS SURGICALLY CHANGED' ON (B)(6) 2012. IT WAS NOT CLEAR WHAT THE REPORTER MEANT BY 'SENSORS.' THE PATIENT WAS STILL NOT GETTING RELIEF AFTER THE SURGERY. IT WAS STATED THAT THE PATIENT WAS UNSURE IF SHE RECEIVED SYMPTOM RELIEF WITH THE TRIAL DEVICE. IT WAS STATED THAT THE PATIENT WAS 'DESPERATE' AND THAT WAS THE REASON FOR HER IMPLANT AFTER THE TRIAL. THE PATIENT WAS PROGRAMMED BETWEEN 3.4 - 4.3 VOLTS, AND THAT 'HURT BEING THAT HIGH.' IT WAS REPORTED THAT THE PATIENT FOUND IT 'REALLY HARD' TO WAKE UP EVERY MORNING AND GET UP 'SOPPING WET.' IT WAS ALSO REPORTED THAT THE PATIENT 'WAS NOT ABLE TO GO ANYWHERE BECAUSE OF NOT HAVING RELIEF.' ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAS HAD 'HYDROTHERAPY MASSAGE THERAPY' 1-2 TIMES BECAUSE SHE WAS 'HURTING.' NO ADVERSE EVENT WAS ATTRIBUTED TO THE MASSAGE THERAPY. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS NOTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE, BUT THEIR CONCERNS WERE NOT RESOLVED. SEVERAL APPOINTMENTS WERE LISTED TO HAVE OCCURRED IN 2012. IT WAS INDICATED THE PATIENT HAD NOT SOUGHT FURTHER HELP. NO FURTHER INFORMATION WAS REPORTED.
ADDITIONAL INFORMATION INDICATED THAT PATIENT WAS NOT FEELING STIMULATION SENSATION FOR A COUPLE OF MONTHS WHILE THE DEVICE WAS ON .NO FALLS OR TRAUMA WAS NOTED .IT WAS INDICATED THAT SHE PEED ON EVERYTHING AND WAS SOPPING WET WHEN USED 3 PADS. IT WAS INDICATED THAT PATIENT BELIEVED SHE HAD GOOD RESULTS WITH TRIAL OTHERWISE HCP WOULD NOT HAVE IMPLANTED, BUT SHE COULD NOT REMEMBER. THE PATIENT WAS CONSIDERING REMOVING THE DEVICE BUT WILL BE SEEKING FOR A SECOND OPINION ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5163 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |