FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3901297
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12592
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- March 27, 2014
- 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
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS. EXTERNAL INSULATION ABRASION WAS NOTED UNDER THE SUTURE SLEEVE AT 41.8-41.9CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT LEAD WAS EXPLANTED DUE TO NOISE. PATIENT CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380447 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |