MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-06-30 for COMPLETE TUNNELING KIT * NL950-VC manufactured by Integra Neurosciences.
[18599204]
The distributor reported on behalf of their customer that the device would not calibrate to zero. It was further reported that although the device was in contact with a pt, the pt did not sustain an injury. The catheter was not zeroed prior to insertion.
Patient Sequence No: 1, Text Type: D, B5
[18684516]
An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2006-00023 |
| MDR Report Key | 734475 |
| Report Source | 08 |
| Date Received | 2006-06-30 |
| Date of Report | 2006-06-27 |
| Date Mfgr Received | 2006-05-31 |
| Date Added to Maude | 2006-07-17 |
| 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 | COMPLETE TUNNELING KIT |
| Generic Name | ICP DISPOSABLES |
| Product Code | HCA |
| Date Received | 2006-06-30 |
| Returned To Mfg | 2006-06-19 |
| Model Number | * |
| Catalog Number | NL950-VC |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 722346 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Baseline Brand Name | COMPLETE VENTRICULAR TUNNELING PRESSURE MONITORING KIT |
| Baseline Generic Name | VENTRIX CATHETER |
| Baseline Model No | NL950-VC |
| Baseline Catalog No | NL950-VC |
| Baseline ID | NONE |
| Baseline Device Family | VENTRIX DISPOSABLES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K904883 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-30 |