FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE-FIXATION LEAD
MDR report key: 1073542
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02436
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 6, 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
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
A PATIENT PRESENTED TO THE CLINIC NOT FEELING WELL. A CAPTURE ANOMALY WAS OBSERVED. A CHEST X-RAY CONFIRMED LEAD PERFORATION IN THE RV APEX. DURING LEAD REVISION, THE PHYSICIAN HAD DIFFICULTY PULLING BACK THE ENTIRE LEAD. DUE TO THE PATIENT'S AGE AND CONDITION, THE PHYSICIAN OPTED TO NOT REMOVE THE LEAD. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE-FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |