FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 3080112
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00955
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- November 15, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE LEAD WAS RETURNED CUT INTO TWO SEGMENTS. EXTERNAL INSULATION ABRASION WAS FOUND AT 12.0-12.4CM AND 18.8-19.3CM FROM THE CONNECTOR PIN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS FOUND AT 21.7- 22.1CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED IN THIS LOCATION. THIS DAMAGE IS CONSISTENT WITH THE FIELD OBSERVATION OF NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP AFTER RECEIVING A SHOCK. INTERROGATION REVEALED INAPPROPRIATE THERAPY DUE TO NOISE. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180887 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7041/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |