MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-15 for NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL * NS-P manufactured by Integra Neurosciences.
[417103]
Three incidents were reported by this user facility. While zeroing the icp portion of the probe, a significant difference between the probe readings in the vial and the probe readings outside the vial were observed. Also mentioned were big differences between cbf measurements from the grey to white matter. The physician expressed a greater concern with the difference in the icp measurements than with the cbf measurements. This medical report is linked to medical device report 2023988-2005-00042 and #2023988-2005-00045.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023988-2005-00044 |
| MDR Report Key | 664302 |
| Report Source | 05 |
| Date Received | 2005-09-15 |
| Date of Report | 2005-09-15 |
| Date Mfgr Received | 2005-08-18 |
| Date Added to Maude | 2006-01-18 |
| 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 | 2005-09-15 |
| Model Number | * |
| Catalog Number | NS-P |
| Lot Number | W050708 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 653725 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| 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 | 2005-09-15 |