FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION LEAD
MDR report key: 4160786
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-01813
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- November 19, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER THE CLINIC SAW ONE EPISODE OF LEAD NOISE ON MERLIN.NET. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26684 | RIATA PASSIVE FIXATION LEAD | LWS | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D | 1570/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |