FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073237
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02500
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 28, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD MEASURING 17.5CM IN LENGTH WAS RETURNED. THE ANALYSIS OF THE RETURNED PORTION EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. AS RECEIVED, THERE IS NO INDICATION OF THE LEAD CAUSING THE REPORTED NOISE OBSERVED. HOWEVER, NO COMPLETE EVALUATION AND ASSESSMENT CAN BE PERFORMED, GIVEN THAT THE LEAD WAS PARTIALLY RETURNED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO NOISE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATES THAT EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE ALREADY CAPPED LEAD DURING FLUOROSCOPY TO EVALUATE ADDITION OF AN ATRIAL LEAD. NO ELECTRICAL ANOMALIES WERE OBSERVED. EXPLANTING THE CAPPED LEAD WAS SUGGESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |