FDA Adverse Event
Injury
Summary report: N
FORTIFY DR, DF-4 CONNECTOR
MDR report key: 1954800
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00499
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 20, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED NO ERRORS RELATING TO HIGH VOLTAGE LEAD IMPEDANCE MEASUREMENTS WERE EXPERIENCED THROUGHOUT DEVICE TESTING. THE DEVICE WAS NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE NOTED NO MEASUREMENT FOR THE SVC VECTOR WHEN THE HIGH VOLTAGE LEAD IMPEDANCE WAS MEASURED. THE POCKET WAS RE-OPENED AND THE DEVICE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORTIFY DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention | (B)(4) |