MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-01-24 for DELTA VALVE, REGULAR, LOW-LOW PRESSURE NA DEVICE 1 24048 manufactured by Medtronic Ps Medical.
[43478]
The valves were implanted by dr in 2 different pts on 12/2/96. His successor found that the pts were not improving. The valves were replaced on 12/16 with valves, low pressure. The pt's conditions improved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-1997-00007 |
| MDR Report Key | 65062 |
| Report Source | 08 |
| Date Received | 1997-01-24 |
| Date of Report | 1996-12-27 |
| Date of Event | 1996-12-16 |
| Report Date | 1996-12-27 |
| Date Reported to Mfgr | 1996-12-27 |
| Date Mfgr Received | 1996-12-27 |
| Date Added to Maude | 1997-01-29 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTA VALVE, REGULAR, LOW-LOW PRESSURE |
| Generic Name | CNS FLUID SHUNT AND COMPONENT |
| Product Code | MAJ |
| Date Received | 1997-01-24 |
| Model Number | NA DEVICE 1 |
| Catalog Number | 24048 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 65170 |
| Manufacturer | MEDTRONIC PS MEDICAL |
| Manufacturer Address | 125 CREMONA DR GOLETA CA 931175500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-01-24 |