FDA Adverse Event
Malfunction
Summary report: N
RIATA/RIATA ST
MDR report key: 8468844
·
Received April 1, 2019
Report
- Report Number
- 2938836-2019-02145
- Event Type
- Malfunction
- Date Received
- April 1, 2019
- Report Date
- April 1, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED IN A RESEARCH ARTICLE IDENTIFYING RIATA/RIATA ST MAY BE RELATED TO INAPPROPRIATE SHOCKS. NO ADDITIONAL INFORMATION WAS PROVIDED ON HOW THE ISSUE WAS RESOLVED. SPECIFIC PATIENT INFORMATION IS UNKNOWN. ROTEN, LAUREN (2018). COMPARISON OF LEAD FAILURE MANIFESTATION OF BIOTRONIK LINOX WITH ST. JUDE MEDICAL RIATA AND MEDTRONIC SPRINT FIDELIS LEAD. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. HTTPS://DOI.ORG/10.1007/S10840-018-0486-0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265097 | RIATA/RIATA ST | LWS | ST. JUDE MEDICAL, INC. | RIATA/RIATA ST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |