FDA Adverse Event
Injury
Summary report: N
NEUROMONITOR BASIC KIT
MDR report key: 1047549
·
Received May 19, 2008
Report
- Report Number
- 1226348-2008-00128
- Event Type
- Injury
- Date Received
- May 19, 2008
- Manufacturer
- CODMAN & SHURTLEFF, INC./MEDOS
- Product Code
- GWM
- PMA / PMN Number
- K914479
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
REP REPORTED THAT THE ICP MONITOR COULD NOT DETECT THE SENSOR. THE MONITOR WAS CHANGED AND IT STILL COULD NOT DETECT IT. AS A RESULT, THE MICRO SENSOR WAS CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROMONITOR BASIC KIT | DEVICE, INTRACRANIAL PRESSURE MONITORING | GWM | CODMAN & SHURTLEFF, INC./MEDOS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |