FDA Adverse Event
Injury
Summary report: N
TVL LEAD, RIGHT VENTRICULAR
MDR report key: 1073060
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02305
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 7, 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
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE FIELD EXPERIENCE OF A CAPTURE ANOMALY WAS NOT CONFIRMED. THE LEAD WAS RETURNED IN TWO PARTS. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALIES WERE FOUND RELATED TO THE FIELD REPORT. ALL NOTICEABLE DAMAGE WAS DUE TO THE SURGICAL PROCEDURE.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO A CAPTURE ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TVL LEAD, RIGHT VENTRICULAR | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | RV02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |