FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 4973511
·
Received August 5, 2015
Report
- Report Number
- 2938836-2015-28489
- Event Type
- Injury
- Date Received
- August 5, 2015
- Date of Event
- June 11, 2015
- Report Date
- June 23, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RVA LEAD HAD OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. THERE WERE NO COMPLICATIONS. THE PATIENT WAS FINE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION THAT THERE WAS NOISE AND LOW LEAD IMPEDANCE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION THAT THERE WAS INNAPROPRIATE HV OUTPUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514229 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 7001/60 | 0002126235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |