MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2008-10-20 for VENTR. TUNNEL.PRESS.KIT NL950-V manufactured by Integra Neurosciences.
[970970]
Icp (intracranial pressure) reading showed an e01 error reading once inserted, but the drainage portion worked normally. According to the directions for use, this type of code can appear after catheter placement, when there is damage to the sensor located at the catheter tip.
Patient Sequence No: 1, Text Type: D, B5
[8216998]
To date, the device in the reported incident has not been received for evaluation. An investigation has been initiated, based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2008-00042 |
| MDR Report Key | 1204640 |
| Report Source | 01,05,08 |
| Date Received | 2008-10-20 |
| Date of Report | 2008-10-20 |
| Date Facility Aware | 2008-10-08 |
| Date Mfgr Received | 2008-10-08 |
| Date Added to Maude | 2009-04-07 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SHARON GREEN, RN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362469 |
| 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 | 2008-10-20 |
| Model Number | NL950-V |
| Catalog Number | NL950-V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-20 |