FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3801352
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-11001
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- August 3, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A CHEST X-RAY SHOWED EROSION OF THE OUTER COATING OF THE LEAD. SUBSEQUENT FOLLOW-UPS SHOWED NO EVIDENCE OF LEAD DAMAGE OR MALFUNCTION. THE PHYSICIAN DECIDED TO CONTINUE MONITORING. IT WAS LATER REPORTED THAT THE LEAD WAS REPLACED COMPETITIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278435 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |