FDA Adverse Event
Malfunction
Summary report: N
CART 9734056 S7 STAFF SHRT 100-120V INTL
MDR report key: 11436095
·
Received March 8, 2021
Report
- Report Number
- 1723170-2021-00598
- Event Type
- Malfunction
- Date Received
- March 8, 2021
- Date of Event
- March 2, 2021
- Report Date
- March 8, 2021
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 9735346R. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. DURING SERVICING, IT WAS FOUND THAT AT THE TIME OF INSPECTION, THE POSITION SENSOR UNIT (PSU) (CAMERA) WAS DISPLAYING LOCALIZER NOT CONNECTED, AND THE ERROR LAMP LIT UP ON THE SYSTEM CONTROL UNIT (SCU). REBOOT WAS PERFORMED BUT IT DID NOT IMPROVE, AND THE PROBLEM STILL OCCURRED. REPLACEMENT OF THE PSU RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334943 | CART 9734056 S7 STAFF SHRT 100-120V INTL | INSTRUMENT, STEREOTAXIC | HAW | MEDTRONIC NAVIGATION, INC | 9734056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |