FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1223125
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03744
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 11, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT SENSING THRESHOLDS HAD DECREASED AND CAPTURE THRESHOLDS HAD INCREASED. AN ECHO CONFIRMED PERFORATION. THE LEAD WAS EXPLANTED. PERICARDIAL EFFUSION WAS NOTED BUT NO INTERVENTION WAS REQUIRED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7002/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |