FDA Adverse Event Malfunction Summary report: N

INTELLIS

MDR report key: 22307747 · Received June 23, 2025

Report

Report Number: 3004209178-2025-10674
Event Type: Malfunction
Date Received: June 23, 2025
Date of Event: June 12, 2025
Report Date: June 23, 2025
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LGW
UDI-DI: 00763000315467
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WV, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES: 800, 780, 700, 730, 740, 760, 690, 730. THE PATIENT ALSO REPORTED HAVING A FALL AND THE STIMULATOR NOT WORKING FOR THEIR PAIN SUDDENLY. THE IMPEDANCE CHECK DISPLAYED 8 CONTACTS, DO NOT USE. THE PATIENT WANTED THEIR PERCUTANEOUS LEADS REPLACED. THEY ALSO WANTED THEIR BATTERY REPLACED WITH INCEPTIV AT THE SAME TIME. THE ISSUE IS ONGOING. THE REPRESENTATIVE NOTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
928912	INTELLIS	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR	LGW	MEDTRONIC PUERTO RICO OPERATIONS CO.	97715		00763000315467

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR	Female