INTERSTIM II
Report
- Report Number
- 3004209178-2025-07074
- Event Type
- Injury
- Date Received
- April 23, 2025
- Date of Event
- January 1, 2013
- Report Date
- July 1, 2025
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- UDI-DI
- 00613994287724
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
CONTINUATION OF D10: PRODUCT ID: 3093-28, LOT# V082175, IMPLANTED: (B)(6) 2008, 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10: PRODUCT ID 3093-28 LOT# V082175 SERIAL# IMPLANTED: (B)(6) 2008; EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# V082175 SERIAL# IMPLANTED:(B)(6) 2008; EXPLANTED: 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.
CONTINUATION OF D10: PRODUCT ID: 3093-28, LOT# V082175, IMPLANTED: (B)(6) 2008, 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.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR INTERSTIM BATTERY WAS TAKEN OUT BECAUSE IT WAS NOT WORKING PROPERLY.
(B)(6) 2025 MENDIX PATIENT REGISTRATION (B)(4) (CON): [SEE (B)(4) FOR REPORT OF LEAD MALFUNCTIONED] INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR INTERSTIM BATTERY WAS TAKEN OUT BECAUSE IT WAS NOT WORKING PROPERLY. (B)(6) 2025 (B)(4) (CON): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE REASON FOR CALL WAS THE PATIENT STATED THAT THEIR INS MALFUNCTIONED AND THEY WERE GOING TO REPLACE IT BUT SOMETHING HAPPENED DURING THE SURGERY, SO THE INS WAS REMOVED.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR INTERSTIM BATTERY WAS TAKEN OUT BECAUSE IT WAS NOT WORKING PROPERLY. IT WAS REPORTED THAT THE PATIENT STATED THAT THE LEAD HAD MALFUNCTIONED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE REASON FOR CALL WAS THE PATIENT STATED THAT THEIR INS MALFUNCTIONED AND THEY WERE GOING TO REPLACE IT BUT SOMETHING HAPPENED DURING THE SURGERY, SO THE INS WAS REMOVED . PATIENT SAID THAT THEY NEED TO DO BRAIN SURGERY AND NEED TO DO MRI, HOWEVER, THEIR NEUROSURGEON TOLD THE PATIENT THAT THEY CANT DO BRAIN SURGERY BECAUSE THERE IS A LEAD IN THE PATIENT'S BLADDER THAT MIGHT SET THE PATIENT ON FIRE. THE AGENT REVIEWED THAT THE NEUROSURGEON SHOULD CONTACT THE TECH SERVICES DIRECTLY. AGENT REVIEWED MEDTRONIC IS NOT HCP. PATIENT SAID THAT DURING THEIR OPERATION TO REMOVE THE INS, THE REP WAS THERE INSIDE THE OPERATING ROOM WITH THE PATIENT'S DOCTOR, BUT THE PATIENT DID NOT KNOW THE REP'S INFORMATION. THE PATIENT COMMENTED THEY RECEIVED A FOLLOW-UP LETTER IN THE MAIL, AND IT IS ASKING QUESTIONS THEY CANNOT KNOW THE ANSWER TO BECAUSE THEY WERE UNDER ANESTHESIA WHEN THE ISSUE OCCURRED. PATIENT REVIEWED MEDTRONIC SHOULD TALK TO THE HCP OR THE SALES REP TO GET THIS INFORMATION. PATIENT SAID THAT THEY WILL HIRE A LAWYER IF THE PATIENT WILL DO ALL OF THE WORK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE DEVICE HAD MALFUNCTIONED AND HAD COME LOOSE. THEY STATED THIS WAS NOT DUE TO NORMAL BATTERY DEPLETION. THEY STATED THAT THE CAUSE WAS DETERMINED TO BE DUE TO THE LEAD COMING LOOSE. WHEN ASKED WHAT STEPS WERE TAKEN TO RESOLVE THE ISSUE THEY STATED THE PHYSICIAN TRIED TO RECONNECT IT BUT WAS NOT SUCCESSFUL. WHEN ASKED ABOUT THE STATUS OF THE DEVICE THE PATIENT STATED THAT THEY DID NOT KNOW AND THAT THE MANUFACTURING REPRESENTATIVE (REP) WAS THERE AT THE TIME OF THE REMOVAL. THE PHYSICIAN WAS NO LONGER PRACTICING AND THEY HAD NO IDEA WHAT HAPPENED TO THE DEVICE. THEY NOTED THEY HAD TRIED TO CONTACT THEM. WHEN ASKED ABOUT THE LEAD MALFUNCTIONING THEY STATED IT WAS DUE TO THE LEAD BECOMING DISLODGED AND THEY COULDN'T REINSERT IT. WHEN ASKED ABOUT THE STEPS TAKEN TO RESOLVE THE ISSUE THEY STATED THAT THE PHYSICIAN WAS GOING TO REMOVE THE LEAD INSIDE THEIR BLADDER. THE SURGERY WAS TENTATIVE FOR (B)(6) 2025 WITH A DIFFERENT SURGEON. THIS HAD NOT YET BEEN RESOLVED. THEY PROVIDED ADDITIONAL INFORMATION STATING THAT THEY WERE SLEEPING WHEN THIS WAS HAPPENING. THEY LANDED IN THE RECOVERY ROOM AND THE DOCTOR STATED THAT THEY COULDN'T RE-INSET THE LEAD. THE REP WAS THERE BUT THEY DIDN'T KNOW IF THE REP TOOK IT OR WHAT THE DOCTOR HAD DONE WITH THE LEAD. THEY STATED THE HOSPITAL NEEDED TO BE CALLED TO SEE IT THEY NOW IF THE PATIENT NEEDED SURGERY AND THEY COULDN'T DO IT WHY THE LEAD WAS IN THEIR BLADDER. THEY NOTED THEY INTENDED TO BE CHARGED FOR THE SURGERY. FOR REMOVAL THEY HAD NO IDEA WHERE IT WAS AND NOTED THAT WAS BETWEEN THE SURGEON AND THE REP WHO WAS PRESENT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE REASON FOR CALL WAS THE PATIENT STATED THAT THEIR INS MALFUNCTIONED AND THEY WERE GOING TO REPLACE IT BUT SOMETHING HAPPENED DURING THE SURGERY, SO THE INS WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726894 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 | 00613994287724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention | "SEE H11...."| "SEE H11...."| "SEE H11...." |