MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-12-20 for VENTR. TUNNEL. PRESS. KIT NL950-V manufactured by Integra Neurosciences.
[20201695]
It was reported that after zero balancing, icp monitoring was conducted for a while; however, the error code eob was displayed and monitoring became impossible. The faulty catheter was replaced. The customer disposed of the catheter. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[20449430]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2007-00078 |
| MDR Report Key | 968443 |
| Report Source | 08 |
| Date Received | 2007-12-20 |
| Date of Report | 2007-12-20 |
| Date Mfgr Received | 2007-11-14 |
| Date Added to Maude | 2008-04-08 |
| 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 | 0 |
| 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 | VENTR. TUNNEL. PRESS. KIT |
| Generic Name | NONE |
| Product Code | HCA |
| Date Received | 2007-12-20 |
| Catalog Number | NL950-V |
| Lot Number | W051090 |
| Device Expiration Date | 2008-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 972900 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-20 |