MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-09-09 for NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL * NS-P manufactured by Integra Neuro Sciences.
[443464]
As reported by the neurosurgeon, he inserted a neurosensor probe and got readings of 0-2cc/100gm/min. The pt had a normal pbto2 but no cbf. Icp worked well and correlated with the camino values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023988-2005-00039 |
| MDR Report Key | 671119 |
| Report Source | 06 |
| Date Received | 2005-09-09 |
| Date of Report | 2005-09-09 |
| Date Mfgr Received | 2005-08-04 |
| Date Added to Maude | 2006-02-07 |
| 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 | NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL |
| Generic Name | NEUROSENSOR |
| Product Code | DPW |
| Date Received | 2005-09-09 |
| Model Number | * |
| Catalog Number | NS-P |
| Lot Number | W050980 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 660439 |
| Manufacturer | INTEGRA NEURO SCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Baseline Brand Name | NEUROSENSOR CBF AND ICP MONITOR CATHETER |
| Baseline Generic Name | NEUROSENSOR |
| Baseline Model No | NS-P |
| Baseline Catalog No | NS-P |
| Baseline Device Family | NEUROSENSOR |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-09 |