FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION LEAD
MDR report key: 4160958
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-01741
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- September 4, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, 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 PT RECEIVED INAPPROPRIATE SHOCK DUE TO OVERSENSING. THE DEVICE WAS REPROGRAMMED AND THE ISSUE WAS RESOLVED. THE LEAD WAS STILL IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27256 | RIATA ST OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL INC., CRMD | 7020/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |