FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1050823
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01769
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 13, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
LOST OF CAPTURE AND HIGH LEAD IMPEDANCE WERE OBSERVED. X-RAY SHOWED THAT THE LEAD HAD MOVED. ULTRASONIC WAS PERFORMED AND REVEALED PERICARDIAL EFFUSION. IT WAS SUSPECTED THAT THE LEAD HAD PERFORATED. AS SUCH, THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |