FDA Adverse Event
Injury
Summary report: N
FORTIFY VR, DF-4 CONNECTOR
MDR report key: 2242950
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06545
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- June 1, 2011
- 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
- AL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED NOISE WAS NOT CONFIRMED. THE STORED EGM ON THE DEVICE IMAGE INDICATED HIGH CYCLE NOISE CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE. NO NOISE OR SENSING ISSUES WERE DETECTED DURING ANALYSIS. THE DEVICE PASSED ALL TESTS.
Description of Event or Problem · 1
IT WAS REPORTED NOISE WAS OBSERVED IN THE HEADER. WHEN THE DEVICE WAS REPLACED WITH ANOTHER DEVICE THERE WAS NO NOISE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORTIFY VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |