FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1073130
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02372
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 3, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A LEAD TIP STIFFNESS TEST WAS PERFORMED, AND WAS FOUND TO BE WITHIN SPECIFICATION. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL.
Description of Event or Problem · 1
SENSING AND PACING ANOMALIES WERE OBSERVED ONE DAY POST- IMPLANT. THE LEAD WAS IMPLANTED IN THE APEX, AND DECISION WAS MADE TO REPOSITION THE LEAD IN THE SEPTUM. DURING THE SURGICAL PROCEDURE, NOISE WAS HEARD WHEN THE LEAD WAS REMOVED. IT WAS SUSPECTED THAT THE LEAD HAD PERFORATED. HENCE, THE LEAD WAS EXPLANTED AND REPLACED WITH NO CONSEQUENCES TO THE PATIENT.
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 | Required Intervention |