INTERSTIM
Report
- Report Number
- 3004209178-2024-14527
- Event Type
- Injury
- Date Received
- July 11, 2024
- Date of Event
- June 28, 2024
- Report Date
- August 21, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- UDI-DI
- 00763000203849
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE LEAD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE HCP STATED THE PATIENT POSSIBLY HAD PART OF THEIR LEAD REMOVED AND THE REST OF IT ABANDONED. THE HCP STATES THAT THE MEDICAL CHART STATES IN 2021 THERE WAS A LEAD FRAGMENT SHOWN ON AN X-RAY AND A NOTE THAT IN 2022 IT WAS REMOVED. THE HCP STATED THE PATIENT TOLD THEM THEY "TALKED TO SOMEONE" (UNCLEAR AT THE TIME OF CALL IF THIS PERSON WAS FROM MDT) AND WERE TOLD THEY COULD STILL HAVE A HEAD MRI. AGENT REVIEWED ASSESSING FOR POSSIBLE LEAD FRAGMENT. HCP PLANNED TO COMPLETE AN X-RAY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HCP CALLED TO GET INTO MRI MODE AND DETERMINE ELIGIBILITY. THE HCP HAD SOME DIFFICULTY GETTING COMMUNICATOR TO CONNECT TO INS AND SAID THE COMMUNICATOR WOULD NOT CONNECT PREVIOUSLY, SO THEY DECIDED TO CALL. AGENT HELPED THE HCP GET COMMUNICATOR CONNECTED TO INS ON CALL. THE HCP ACCESSED MRI MODE AND SAW THE PATIENT HAD MRI ELIGIBILITY CANNOT BE DETERMINED: 0151310. SCREEN ALSO SAID PATIENT HAD ABANDONED PRODUCT. THE HCP SAID THEY JUST SPOKE TO THE MANAGING HCP WHO SAID THE PATIENT DID NOT HAVE ABANDONED PRODUCT. AGENT SUGGESTED THE PATIENT(PT) FOLLOW UP WITH HCP TO HAVE PROGRAMMING CHANGED. PT WAS ESCALATED IN BACKGROUND AND SEEMED FRUSTRATED THEY COULD NOT HAVE MRI. PT SAID "BROCHURE" SAYS FINE WHETHER THERE IS A LEAD THERE OR NOT. ABANDONED PRODUCT NOT REFLECTED IN REGISTRATION.
***MDR DECISION UPDATED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.***
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE HCP STATED THE PATIENT POSSIBLY HAD PART OF THEIR LEAD REMOVED AND THE REST OF IT ABANDONED. THE HCP STATES THAT THE MEDICAL CHART STATES IN 2021 THERE WAS A LEAD FRAGMENT SHOWN ON AN X-RAY AND A NOTE THAT IN 2022 IT WAS REMOVED. THE HCP STATED THE PATIENT TOLD THEM THEY "TALKED TO SOMEONE" (UNCLEAR AT THE TIME OF CALL IF THIS PERSON WAS FROM MDT) AND WERE TOLD THEY COULD STILL HAVE A HEAD MRI. AGENT REVIEWED ASSESSING FOR POSSIBLE LEAD FRAGMENT. HCP PLANNED TO COMPLETE AN X-RAY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HCP CALLED TO GET INTO MRI MODE AND DETERMINE ELIGIBILITY. THE HCP HAD SOME DIFFICULTY GETTING COMMUNICATOR TO CONNECT TO INS AND SAID THE COMMUNICATOR WOULD NOT CONNECT PREVIOUSLY, SO THEY DECIDED TO CALL. AGENT HELPED THE HCP GET COMMUNICATOR CONNECTED TO INS ON CALL. THE HCP ACCESSED MRI MODE AND SAW THE PATIENT HAD MRI ELIGIBILITY CANNOT BE DETERMINED: 0151310. SCREEN ALSO SAID PATIENT HAD ABANDONED PRODUCT. THE HCP SAID THEY JUST SPOKE TO THE MANAGING HCP WHO SAID THE PATIENT DID NOT HAVE ABANDONED PRODUCT. AGENT SUGGESTED THE PATIENT(PT) FOLLOW UP WITH HCP TO HAVE PROGRAMMING CHANGED. PT WAS ESCALATED IN BACKGROUND AND SEEMED FRUSTRATED THEY COULD NOT HAVE MRI. PT SAID "BROCHURE" SAYS FINE WHETHER THERE IS A LEAD THERE OR NOT. ABANDONED PRODUCT NOT REFLECTED IN REGISTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340817 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97810 | 00763000203849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |