InjuryISP
ST. JUDE MEDICAL
Received Aug 29, 1994 · Event occurred Jan 15, 1994
Report 16740 · MDR key 16740
Device
Generic name
Prosthetic Mitral Valve
Manufacturer
St. Jude Medical, Inc.Model number
29M101Catalog number
NI
Lot number
NI
Product problems
- No Device Output
Patient
42 *
- Embolus
- Fever
- Unspecified Infection
Narrative
Description of Event or Problem
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.