FDA Adverse Event
Death
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1171743
·
Received September 24, 2008
Report
- Report Number
- 2017865-2008-03179
- Event Type
- Death
- Date Received
- September 24, 2008
- Date of Event
- July 2, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT AS OF 2008, NO DISCHARGE OF ICD WAS NOTED. HOWEVER, FAMILY STATED THAT THE PATIENT REPORTED DISCHARGES AND COMPLAINED OF MULTIPLE SYNCOPAL EPISODES IN APPROX THREE MONTHS LATER. THE PATIENT DIED IN THE HOME. PATIENT HAD CORONARY ARTERY DISEASE AND ACUTE MYOCARDIAL INFARCTION. DEVICE MALFUNCTION SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |