INTERSTIM II
Report
- Report Number
- 3004209178-2024-21785
- Event Type
- Injury
- Date Received
- November 11, 2024
- Date of Event
- November 7, 2024
- Report Date
- March 25, 2025
- 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
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H3: ANALYSIS RESULTS OF THE ASSOCIATED LEAD WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. H6: IME UPDATED/CORRECTED TO E2401. 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: 978B128; LOT#: VA2PS6E; IMPLANTED: (B)(6) 2022; EXPLANTED: (B)(6) 2024; PRODUCT TYPE: LEAD. PRODUCT ANALYSIS (B)(4): ANALYSIS IDENTIFIED THAT THE CONDUCTORS WERE BROKEN IN THE BODY OF THE LEAD AT OR NEAR THE TINES. 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 978B128, LOT# VA2PS6E, IMPLANTED: (B)(6) 2022, EXPLANTED: (B)(6) 2024, 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.
B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SURESCAN; PRODUCT ID 978B128 (LOT: VA2PS6E); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2022; 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.
2024-NOV-07 MPXR 1240617 (HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT NO LONGER FELT ANY STIMULATION AND PRESENTED THEMSELVES FOR CONSULTATION. PERFORMED AN IPG CONTROL. ALL IMPEDANCES WERE ABOVE 4000 OHMS. THERE IS NO EXPLAINABLE REASON, NO EXAMINATION, SURGERY OR FALL. SURGERY APPOINTMENT TO CHANGE THE ELECTRODE PLANNED. XRAY FROM LATERAL COCCYX WE PERFORM BEFORE THE OPERATION. THE ISSUE WAS RESOLVED. ON (B)(6) 2024, E1, E2, IMAGE X2 (FOR, REP): ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE LEAD WAS REMOVED ON (B)(6) 2024. ON (B)(6) 2024 E3, IMAGE X2 (REP): NO NEW INFORMATION FOR EVENT DESCRIPTION 2025-JAN-22, E4, 2 IMAGES (FOR, REP): NO NEW INFORMATION. ON (B)(6) 2025, E5, 2 IMAGES, SIGNED GERMAN CONSENT FORM (FOR, REP): NO NEW INFORMATION. ON (B)(6) 2025 AN_RP (FOR, REP): NO NEW INFORMATION.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE LEAD WAS REMOVED ON (B)(6) 2024.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT NO LONGER FELT ANY STIMULATION AND PRESENTED THEMSELF FOR CONSULTATION. PERFORMED AN IPG CONTROL. ALL IMPEDANCES WERE ABOVE 4000 OHMS. THERE IS NO EXPLAINABLE REASON, NO EXAMINATION, SURGERY OR FALL. SURGERY APPOINTMENT TO CHANGE THE ELECTRODE PLANNED. XRAY FROM LATERAL COCCYX WE PERFORM BEFORE THE OPERATION. THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 972299 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |