FDA Adverse Event
Death
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984534
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00328
- Event Type
- Death
- Date Received
- February 28, 2013
- Date of Event
- February 1, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD MEASURING 13.9CM FROM CONNECTOR PIN WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-HOSPITAL FOR DEVICE CHANGE-OUT DUE TO NORMAL ERI AND ELECTIVE LEAD EXTRACTION. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. DURING THE EXTRACTION, A DROP IN BLOOD PRESSURE WAS OBSERVED AS THE PHYSICIAN ENTERED THE SVC JUNCTION. THE PROCEDURE WAS ONGOING BUT THE PATIENT HAD NOT STABILIZED. THE SVC WAS TORN AND COULD NOT BE REPAIRED. PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88606 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |