MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-04 for HERMATIC LUMBAR CATHETER CLOSED TIP UNK manufactured by Integra Neurosciences.
[365086]
In 2003, during insertion of a spinal drain, the guidewire became unraveled. It was thought that the entire plastic catheter and guide wire were removed at the completion of the surgery. It was not until a year later and a history of back and leg pain, that an x-ray showed a retained piece of guidewire and catheter in their back. Pt has required surgery to remove this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 526938 |
| MDR Report Key | 526938 |
| Date Received | 2004-05-04 |
| Date of Report | 2004-04-01 |
| Date of Event | 2003-02-01 |
| Date Added to Maude | 2004-05-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERMATIC LUMBAR CATHETER CLOSED TIP |
| Generic Name | LUMBAR CATHETER |
| Product Code | MAJ |
| Date Received | 2004-05-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 516102 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | 309 COMMERCE DR EXTON PA 19341 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-04 |