MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-09-23 for NEUROMONITOR, 220-240C 82-6601 manufactured by Johnson And Johnson Professional, Inc..
[70602]
The icp graph/icp value did not correspond to the pt's actual condition. The pt's condition worsened, while the monitor showed a value within an acceptable range. Because this complaint was reported through co's foreign facility in thailand, and english is not their first language. The condition of the pt is unk and the actual events of the the incident are not clear. The pt has died, but is not known what precipitated the death. Mon/control unit cable, p/c 82-6622, mdr#1219655-1997-00142. Cranial drill bit, 5. 8mm, 82-6608, mdr#1219655-1997-00143. Neuromonitor basic kit, p/c 82-6631, mdr#1219655-1997-00144.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1997-00141 |
| MDR Report Key | 122123 |
| Report Source | 05 |
| Date Received | 1997-09-23 |
| Date of Report | 1997-09-23 |
| Date of Event | 1997-08-01 |
| Date Mfgr Received | 1997-08-22 |
| Date Added to Maude | 1997-09-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROMONITOR, 220-240C |
| Generic Name | SPINAL FLUID PRESSURE MONITOR, ELECTRICAL |
| Product Code | CAR |
| Date Received | 1997-09-23 |
| Model Number | NA |
| Catalog Number | 82-6601 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 119612 |
| Manufacturer | JOHNSON AND JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | NEUROMONITOR, 220-240C |
| Baseline Generic Name | SPINAL FLUID PRESSURE MONITOR, ELECTRICAL |
| Baseline Model No | NA |
| Baseline Catalog No | 82-6601 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Death | 1997-09-23 |