FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4153667
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16363
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 11, 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
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 52.3CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 44.0-44.3CM AND 46.3-46.6CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. INTERNAL INSULATION ABRASION WAS NOTED AT 13.5-14.5CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT, EXTERNALIZED CONDUCTORS ON THE DISTAL PORTION OF THE LEAD WAS OBSERVED. DURING INTERROGATION, VARIATION IN CAPTURE THRESHOLD WAS ALSO OBSERVED. LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631884 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention |