FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1223327
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03681
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 12, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND THAT THE LEAD INSULATION WAS ABRADED IN MULTIPLE PLACES, DUE TO FRICTION WITH THE ICD CAN.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RV SENSING WAS UNSTABLE. THE SENSE/ PACE PORTION OF THE LEAD WAS CAPPED AND REPLACED. THE DEFIB PORTION OF RV LEAD REMAINS ACTIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SNAP SHUNT DISCONNECTION WAS RETROSPECTIVELY CONFIRMED BY REVIEWING AN OPERATIVE REPORT. THE PT HAD COME IN 8 MONTHS AGO FOR A SHUNT MALFUNCTION. IT WAS APPARENT THAT THE SHUNT HAD BROKEN OFF AT THE ATTACHMENT OF THE VENTRICULAR CATHETER TO THE RESERVOIR DOME, AND THE CATHETER WAS LODGED IN THE BRAIN. THE CATHETER WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |