FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2973328
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00134
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- December 30, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED. HIGH CAPTURE THRESHOLD WAS NOTED. LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION AFTER THE EVENT WAS GOOD.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT HIGH IMPEDANCE MEASUREMENTS WERE ALSO OBSERVED ON THE RV LEAD. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED PAIN DURING THE LEAD CAPPING PROCEDURE. LEAD WAS CAPPED AND REPLACED ON (B)(6) 2012 WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75896 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |