FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1050875
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01817
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 28, 2008
- 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 A DECREASE IN SENSING AND INCREASE IN CAPTURE THRESHOLD WAS OBSERVED. IT WAS NOTED THAT THE LEAD HAD NO SLACK, BUT WAS VERTICAL. THE LEAD WAS REPLACED. THE PHYSICIAN BELIEVES THE ANOMALIES WERE A RESULT OF THE PATIENT'S EXCESSIVE PHYSICAL ACTIVITY AND NOT A LEAD MALFUNCTION. THE LEAD WILL NOT BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |