MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2006-07-19 for PARENCHYMAL BOLT PRESSURE MONITORING KIT * NL950-P manufactured by Integra Neuro Sciences.
[490303]
A male pt arrived at the icu in 2006, for severe cranial traumatism management, following an accident in the st. Upon arrival, he presented a glasgow score of 5, that triggered an orotracheal intubation. Cerebral scanner showed a major cerebral edema with suspicion of right carotid dissection. An icp transducer was placed, icp values were paradoxically low, below 15mmhg. A cerebral scanner for control was performed and showed the right transducer position in intraparenchymal tissue. Over the following hours, the displayed icp values became negative so around 12 hours after the first trnasducer was placed, the decision was made to replace it. For the second procedure, a new catheter was used with the same monitor, and the icp value was 50mmhg. The facility's hypothesis at the time was that a calibration error was made prior to placement of the first transducer, even though the same operators performed both procedures.
Patient Sequence No: 1, Text Type: D, B5
[7849034]
An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2006-00032 |
| MDR Report Key | 740338 |
| Report Source | 01,05,06 |
| Date Received | 2006-07-19 |
| Date of Report | 2006-07-18 |
| Date of Event | 2006-04-01 |
| Date Mfgr Received | 2006-06-16 |
| Date Added to Maude | 2006-07-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | PARENCHYMAL BOLT PRESSURE MONITORING KIT |
| Generic Name | ICP DISPOSABLES |
| Product Code | HCA |
| Date Received | 2006-07-19 |
| Model Number | * |
| Catalog Number | NL950-P |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 728210 |
| Manufacturer | INTEGRA NEURO SCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-19 |