FDA Adverse Event
Injury
Summary report: N
FORTIFY ASSURA DR
MDR report key: 3220322
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04489
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 23, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE IMPLANT PROCEDURE, AFTER INDUCING AND DELIVERING A SHOCK A MESSAGE STATING POSSIBLE HIGH VOLTAGE LEAD ISSUE PRESENT. THE POCKET WAS REOPENED AND THE SETSCREWS WERE TIGHTENED. ANOTHER HIGH VOLTAGE LEAD IMPEDANCE CHECK WAS DONE AND STILL MEASURED LOW. A NEW LEAD WAS IMPLANTED AND WHEN CONNECTED TO THE DEVICE, A MESSAGE STATING NO MEASUREMENT ACROSS ALL VECTORS WERE OBSERVED. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320284 | FORTIFY ASSURA DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |