FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 7724943
·
Received July 26, 2018
Report
- Report Number
- 2017865-2018-11012
- Event Type
- Injury
- Date Received
- July 26, 2018
- Date of Event
- July 17, 2018
- Report Date
- November 21, 2018
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THE LEAD WAS CAPPED AND REPLACED ON 7/18/2018 INSTEAD OF 7/19/2018.
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
NEW INFORMATION STATES THAT THE LEAD WAS CAPPED AND REPLACED ON 7/18/2018 INSTEAD OF 7/19/2018.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED NON SUSTAINED RIGHT VENTRICLE OVERSENSING. THE PATIENT DID NOT RECEIVE THERAPY DUE TO OVERSENSING. ON (B)(6) 2018, THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565438 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1580/65 | 0002434966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |