INTERSTIM
Report
- Report Number
- 2182207-2022-00412
- Event Type
- Malfunction
- Date Received
- March 14, 2022
- Date of Event
- March 8, 2022
- Report Date
- April 6, 2022
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEIR SYSTEM REPLACED YESTERDAY SO THEY COULD HAVE FULL-BODY MRIS, REPORTED THAT THEY HAD BEEN DEALING WITH PAIN SINCE THE IMPLANT WAS PLACED. THE PATIENT STATED THEY THOUGHT IT WAS JUST FROM THE SURGERY, HOWEVER NOW THEY THOUGHT THE STIMULATION WAS TOO HIGH AND THEY NEEDED ASSISTANCE IN TURNING IT DOWN. THE PATIENT STATED THAT WHEN THE HEALTH CARE PROVIDERS (HCP) REVIEWED THE IMPLANT AND THE EXTERNAL COMPONENTS WITH THE PATIENT AFTER THE IMPLANT, THE PATIENT WAS COMING OFF OF THEIR MEDS/"ALL DOPED UP" AND THEY DIDN'T REMEMBER HOW TO USE ANYTHING. PATIENT SERVICES OFFERED TO ASSIST THE PATIENT IN TURNING THEIR STIMULATION DOWN AND AS THE PATIENT MOVED TO GET THEIR EXTERNAL EQUIPMENT, THE PATIENT STATED THAT "LITERALLY STANDING UP, IT HURTS," ON THE LEFT SIDE AND THAT IT FELT LIKE THEY WERE GETTING ELECTROCUTED IN THEIR "HOO-HAH." THE PATIENT WAS PANTING AND MADE GRUNTS OF PAIN AS THEY WALKED TO GET THEIR EQUIPMENT. THE PATIENT STATED THAT IN ADDITION TO THIS PAIN, THEY WERE DEALING WITH 3 BIG INCISIONS SO THEY ASKED PATIENT SERVICES TO "BEAR WITH" THEM. THE PATIENT ALSO STATED IT HURT TO SIT. THE PATIENT WAS ABLE TO CONNECT TO THEIR IMPLANT ON THE CALL AND DECREASE THE STIMULATION TO A COMFORTABLE LEVEL. THE PATIENT CONFIRMED THAT THE PAIN WAS RESOLVED. THE PATIENT STATED THEY KNEW THIS BECAUSE NOW THEY COULD FEEL THEIR INCISION AGAIN. THE PATIENT STATED THEY NOTICED THIS PAIN FROM THE SECOND THEY WERE GETTING INTO THEIR CAR YESTERDAY AFTER THE IMPLANT AND THAT IT HAD BEEN EXCRUCIATING. THE PATIENT STATED IT FELT LIKE THEY HAD FIRE GOING INTO THEIR "HOO-HA." THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED THE PATIENT HAS HAD 3 UNRELATED SURGERIES RECENTLY, ONE OF WHICH WAS HAND SURGERY SO THEY WERE DOPED UP ON ALL KINDS OF MEDICATION. THE PATIENT ALSO MENTIONED THAT THEY COULDN'T SEE COLORS ON THE CALL AS THEIR EYES WERE "ALL MESSED UP." PATIENT SERVICES ASKED FOR THE SERIAL NUMBER OF THE IMPLANT OFF OF THE TEMPORARY ID CARD HOWEVER THE PATIENT COULD NOT FIND THE CARD TO GIVE THE SERIAL NUMBER.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE CAUSE OF THE STIMULATION BEING TOO STRONG IS UNKNOWN, BUT THE PATIENT DOES HAVE A FOLLOW-UP APPOINTMENT ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282704 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | 97810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |