FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2242718
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06015
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- May 23, 2011
- 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 ANALYSIS FOUND A SHORT CIRCUIT BETWEEN THE PACING COIL AND SENSING CABLES DUE TO INSIDE ABRASION UNDER THE SVC SHOCK COIL. AN INSULATION ABRASION WAS NOTED AT 55.5CM - 57.5CM FROM THE CONNECTOR PIN, EXPOSING THE SENSING CABLES. FURTHER ANALYSIS FOUND OUTER INSULATION ABRASION ON THE IS-1 CONNECTOR, CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN.
Description of Event or Problem · 1
THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING INAPPROPRIATE SHOCK. AN INCREASE IN IMPEDANCE WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |