MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2007-03-15 for SUBDURAL TUNNELING KIT * NL950-D manufactured by Integra Neurosciences.
[655794]
The user facility reported two incidents in which after insertion of the catheter, the intracranial pressure (icp) values were not reliable. The user facility replaced the catheter and the new device functioned properly. Two catheters are available for investigation, one from lot w051614, the other from unk lot number. No pt injury is reported. This med device report is linked with med device report# 2023988-2007-00015.
Patient Sequence No: 1, Text Type: D, B5
[7975001]
To date the involved device has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2007-00014 |
| MDR Report Key | 872228 |
| Report Source | 01,06,07 |
| Date Received | 2007-03-15 |
| Date of Report | 2007-03-14 |
| Date Mfgr Received | 2007-02-22 |
| Date Added to Maude | 2007-06-28 |
| 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 | 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 | SUBDURAL TUNNELING KIT |
| Generic Name | ICP DISPOSABLES |
| Product Code | HCA |
| Date Received | 2007-03-15 |
| Model Number | * |
| Catalog Number | NL950-D |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 852731 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-15 |