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.
[20025257]
A cbf (cerebral blood flow) monitor and evd were placed. The surgeon did not utilized a licox. The cbf and icp waveform never materialized at either 20mm or 25mm depths. The neurosurgeon felt it may have been attributed to the pt's skull pathology. The pt's head ct was viewed and the skull appeared very thick, it was also observed that the neurosurgeon placed the catheters more anterior than what the directions for use (dfu) recommends. Given the thick bone and unk depth of the subarachnoid space, the catheter may be located in the parenchyma. Low cbf and icp values were observed, however, the waveform was a flat line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023988-2005-00037 |
| MDR Report Key | 671250 |
| Report Source | 06 |
| Date Received | 2005-09-09 |
| Date of Report | 2005-09-09 |
| Date Mfgr Received | 2005-07-11 |
| 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 | 311 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 | 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 | 660570 |
| 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 |