FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223227
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03711
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 30, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE ON THE LEAD WAS OBSERVED VIA REVIEW OF THE EGMS. FOUR ABORTED EPISODES WERE NOTED. PACING LEAD IMPEDANCE DECREASED SLIGHTLY. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRIC OR POSITIONAL TESTING. THE PATIENT EXPERIENCED CLAVICULAR CRUSH. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |