FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1073589
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02473
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 21, 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 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 ONE MONTH POST IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND DIAPHRAGMATIC STIMULATION. LOW IMPEDANCE, LOW SENSING AND HIGH CAPTURE THRESHOLD WAS OBSERVED. THE LEAD WAS EXTRACTED WITH NO FURTHER COMPLICATIONS. THE PATIENT IS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7002/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |