FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1050662
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01624
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 10, 2007
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED SEVERE LEFT-SIDED PLEURITIC CHEST PAIN. IT WAS DETERMINED THAT THE RV WAS PERFORATED. A LEAD REPOSITION WAS PERFORMED IN 2007. UPON INTERROGATION OF THE DEVICE AT FOLLOW-UP, INTERMITTENT PACING AND LOW OUTPUT WERE OBSERVED. THE LEAD WAS REPOSITIONED AGAIN ABOUT ONE WEEK LATER, ONCE AGAIN DUE TO PERFORATION. POST OPERATIVE TESTING REVEALED DIAPHRAGMATIC STIMULATION AND PERICARDIAL EFFUSION. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |