INTERSTIM
Report
- Report Number
- 2182207-2024-03130
- Event Type
- Malfunction
- Date Received
- July 15, 2024
- Report Date
- January 6, 2025
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD SERIAL# UNKNOWN PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN B3: DATE OF EVENT NO INFORMATION AT THE TIME. EVENT DATE REQUESTED FOR. G2: COUNTRY JAPAN. 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.
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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S TREATMENT IMPEDANCE AND ELECTRODE IMPEDANCE ARE DIFFERENT. IN WHICH IT WAS EXPLAINED THAT THESE WILL BE DIFFERENT AS THEY ARE MEASURED BY DIFFERENT PARAMETERS. MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE TREATMENT IMPEDANCE WAS HIGH AT 74,661 WITH CURRENT PARAMETERS OF 1.1V, RATE 28HZ, AND PULSE 210. THE CROSS ELECTRODE IMPEDANCE VARIED; 672, 985, 1016, 631, 1049, 1049, 1049, 1084, 1084, AND 1049. FURTHERMORE, THE PHYSICIAN MEASURES THE PATIENT'S IMPEDANCE REGULARLY. AND THE SAME TROUBLE HAPPENED EVERY TIME AT THIS TIME. EVEN BEFORE THE PATIENT FELL ON THEIR BUTTOCKS, THERE WARE OCCASIONAL HIGH IMPEDANCE, BUT AFTER THE FALL, THE HIGH IMPEDANCE HAS BEEN ABNORMAL EVERY TIME. THEY HAVE ALREADY ATTEMPTED RE-INTERROGATING AND REPEATING THE MEASUREMENT IMPEDANCE. IN ADDITION, REP HAS ASKED TO USEA DIFFERENT HANDSET AND ANOTHER PARAMETER FOR MEASURING AN IMPEDANCE.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED REP WAS CURRENTLY IN THE PROCESS OF ASKING THE CLINICAL ENGINEER FOR THE DATE AND TIME OF THE PATIENT'S NEXT VISIT. IT WAS ALSO UNCLEAR WHETHER THE ISSUE HAS BEEN RESOLVED AT THIS TIME. MORE INFORMATION TO COME.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT DID NOT VISIT THE HOSPITAL AS SCHEDULED, SO NO FURTHER INFORMATION COULD NOT BE OBTAINED.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED SAME TROUBLE HAS OCCURRED. SINCE THE SAME TROUBLE IS OCCURRING IN MORE THAN ONE CASE, THERE MUST BE SOME CAUSE. AND IT COULD HAPPEN AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714664 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC NEUROMODULATION | NEU_INTERSTIM_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |