FDA Adverse Event
Malfunction
Summary report: N
NIM-2 PATIENT INTERFACE PROTECTED PIN
MDR report key: 288210
·
Received August 4, 2000
Report
- Report Number
- 1045254-2000-00012
- Event Type
- Malfunction
- Date Received
- August 4, 2000
- Date of Event
- January 1, 2000
- Report Date
- July 18, 2000
- Manufacturer
- MEDTRONIC XOMED
- Product Code
- IKN
- Removal / Correction Number
- 1045254-8/2/00-001R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER FACILITY REPORTED THAT IMPEDANCES SHOW UP ON THE NIM MONITOR WHEN THERE IS NOTHING CONNECTED TO THE PATIENT INTERFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NIM-2 PATIENT INTERFACE PROTECTED PIN | NERVE MONITORING ACCESSORY | IKN | MEDTRONIC XOMED | NA | 19271900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |