FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4153670
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16364
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- August 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
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 41.0CM WAS RETURNED FOR ANALYSIS. INTERNAL INSULATION ABRASION WAS NOTED AT 8.9-10.5CM AND 12.3-13.2CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INSULATION DAMAGE WAS NOTED AT 31.2-33.0CM FROM THE DISTAL TIP, CONSISTENT WITH CLAVICLE CRUSH. THE INNER COIL WAS EXPOSED AND THE RE CONDUCTOR WAS DAMAGED AT THIS LOCATION, CONSISTENT WITH THE FIELD OBSERVATION OF LOW LEAD IMPEDANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DECREASE PACING LEAD IMPEDANCE AND SUSPECTED INSULATION ANOMALY WERE OBSERVED. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631885 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |