FDA Adverse Event
Injury
Summary report: N
NEUROMONITOR BASIC KIT
MDR report key: 1961029
·
Received January 11, 2011
Report
- Report Number
- 1226348-2011-00005
- Event Type
- Injury
- Date Received
- January 11, 2011
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- GWM
- PMA / PMN Number
- K914479
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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
CUSTOMER REPORTED THAT: "A MICROSENSOR WAS IMPLANTED AND ZEROED WITHOUT ANY ISSUES; HOWEVER, WHEN THE TRANSDUCER WAS DISCONNECTED AND CONNECTED AGAIN, THE SENSOR WOULD NOT WORK PROPERLY. IT WOULD ASK TO RE-ZERO THE SYSTEM AGAIN. THIS HAPPENED WITH TWO DIFFERENT MICROSENSORS OF THE SAME LOT NUMBER IN THE SAME PATIENT. A THIRD MICROSENSOR WAS IMPLANTED, BUT THIS TIME IT WAS NOT DISCONNECTED, AND IT FUNCTIONED PROPERLY. PATIENT IS IN STABLE CONDITION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROMONITOR BASIC KIT | DEVICE INTRACRANIAL PRESSURE MONITORING | GWM | CODMAN & SHURTLEFF, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |