FDA Adverse Event
Malfunction
Summary report: N
NIM-ECLIPSE® PATIENT MODULE
MDR report key: 7075491
·
Received December 1, 2017
Report
- Report Number
- 1045254-2017-00438
- Event Type
- Malfunction
- Date Received
- December 1, 2017
- Date of Event
- November 7, 2017
- Report Date
- January 9, 2018
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- GWF
- UDI-DI
- 00613994870810
- PMA / PMN Number
- K061639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION. THE SERVICING FOUND THE HOUSING/CASING WAS TORN, THE DECAL WAS TORN, AND THE CABLE REQUIRED REPLACEMENT. THE COMPONENTS WERE REPLACED AND THE DEVICE TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE CUSTOMER REQUESTED A RETURN. THERE WERE NO CUSTOMER COMMENTS NOTED. HOWEVER, "ALLEGED DEFECT" WAS CODED FOR SERVICING.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED: THE DEVICE WAS RETURNED DUE TO IT NOT REGISTERING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 854950 | NIM-ECLIPSE® PATIENT MODULE | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | GWF | MEDTRONIC XOMED INC. | OPM660 | 206139396 | 00613994870810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |