FDA Adverse Event
Malfunction
Summary report: N
XPS® BUR - UNKNOWN
MDR report key: 22952308
·
Received September 3, 2025
Report
- Report Number
- 1045254-2025-02088
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 7, 2025
- Report Date
- September 3, 2025
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- EQJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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 INDIGO ATTACHMENT THE BUR CAME OFF. THERE WAS NO KNOWN PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2234092 | XPS® BUR - UNKNOWN | BUR, EAR, NOSE AND THROAT | EQJ | MEDTRONIC XOMED INC. | XOM UNK BUR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |