FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1050890
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01832
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- January 17, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
PATIENT PRESENTED 2 DAYS POST IMPLANT WITH HEMATOMA. POCKET WAS DRAINED. PATIENT RETURNED 3 DAYS LATER AND SITE LOOKED WELL. LATER THAT DAY,PATIENT WAS IN CAR COLLISION AND SUSTAINED A MILD CARDIAC CONTUSION. INAPPROPRIATE THERAPY DUE TO OVERSENSING WAS ALSO NOTED. TWO WEEKS LATER, PATIENT HAD SUDDEN ONSET OF BLEEDING AT THE SITE. THE ENTIRE SYSTEM WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |