FDA Adverse Event
Injury
Summary report: N
MICROSENSOR VENTRICULAR CATHETER KIT
MDR report key: 6154543
·
Received December 8, 2016
Report
- Report Number
- 1226348-2016-10845
- Event Type
- Injury
- Date Received
- December 8, 2016
- Date of Event
- November 6, 2016
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- GWM
- PMA / PMN Number
- K991222
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON COMPLETION OF INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
UPDATED UDI: (B)(4). A REVIEW OF MANUFACTURING RECORDS FOUND NO DISCREPANCIES WHEN THE DEVICE WAS RELEASED TO STOCK. THE DEVICE WAS RETURNED AND EVALUATED. MICROSENSOR WAS TESTED WITH ICP EXPRESS. IT WAS DETECTED, CALIBRATED PROPERLY, AND MEASURED PRESSURE WHEN SUBMERGED INTO THE WATER. NO LEAK DESCRIBED BY THE CUSTOMER WAS OBSERVED. DEVICE FUNCTIONED AS INTENDED. NO FURTHER INVESTIGATION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
Description of Event or Problem · 1
DURING ICP MONITORING IT WAS NOTED THAT CSF LEAKED. CHANGED THE NEW SENSOR TO COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 805832 | MICROSENSOR VENTRICULAR CATHETER KIT | DEVICE, INTRACRANIAL PRESSURE MONITORING | GWM | CODMAN & SHURTLEFF, INC. | 690938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |