MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-04-19 for VENTR.TUNNEL.PRESS.KIT * NL950-V manufactured by Integra Neuro Sciences.
[729115]
The distributor has reported on behalf of their customer that the catheter was zero balanced prior to insertion. It was further reported that after insertion, intracranial pressure monitoring was conducted for awhile and error code "e01" displayed and the device stopped monitoring.
Patient Sequence No: 1, Text Type: D, B5
[7895719]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2007-00028 |
| MDR Report Key | 946677 |
| Report Source | 08 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-04-19 |
| Date Mfgr Received | 2007-03-26 |
| Date Added to Maude | 2007-11-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LINDA GOODSTEIN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTR.TUNNEL.PRESS.KIT |
| Generic Name | * |
| Product Code | HCA |
| Date Received | 2007-04-19 |
| Model Number | * |
| Catalog Number | NL950-V |
| Lot Number | WO50681 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 918783 |
| Manufacturer | INTEGRA NEURO SCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-19 |