FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION LEAD
MDR report key: 1073579
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02463
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. COMPETITOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT OVERSENSING, NOISE, AND PACING INHIBITION WERE OBSERVED. THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE POCKET WAS OPENED AND THE RV AND LV LEADS WERE REVERSED IN THE CONNECTOR HEADER TO ALLEVIATE THE STIMULATION AND TO ALLOW LV PACE/SENSE ONLY. BOTH LEADS REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |