MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-29 for ST. JUDE MEDICAL 29M101 manufactured by St. Jude Medical, Inc..
[12985]
Patient developed prosthetic valve endocarditis 6 months following mitral valve replacement. Patient presented 72 hours prior to explantation with acute fever & rigors, feeling acutely ill. 4 blood cultures were positive. Patient continued to have high fever & signs despite triple antibiotic therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16740 |
| MDR Report Key | 16740 |
| Date Received | 1994-08-29 |
| Date of Report | 1994-03-02 |
| Date of Event | 1994-01-15 |
| Date Facility Aware | 1994-01-15 |
| Report Date | 1994-03-02 |
| Date Reported to Mfgr | 1994-03-02 |
| Date Added to Maude | 1994-10-12 |
| 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 | 0 |
| 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 | ST. JUDE MEDICAL |
| Generic Name | PROSTHETIC MITRAL VALVE |
| Product Code | ISP |
| Date Received | 1994-08-29 |
| Model Number | 29M101 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 9 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 16673 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 1 LILLEHAI PLAZA ST. PAUL MN 551171799 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-29 |