FDA Adverse Event
Injury
Summary report: N
FORTIFY DR, DF-4 CONNECTOR
MDR report key: 1954771
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00492
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 7, 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
- GA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXHIBITING HIGH IMPEDANCE SINCE IMPLANT. CAPTURE THRESHOLD HAD ALSO INCREASED. UPON OPENING THE POCKET, IT WAS OBSERVED THAT THE SETSCREW WAS NOT COMPLETELY ACTIVATED AND THE LEADHAD PULLED BACK SLIGHTLY FROM THE HEADER. THE CASE WAS CLINICALLY RESOLVED BY TIGHTENING THE SETSCREW. HENCE, THE SYSTEM REMAINS IMPLANTED.
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 | 79 YR | Required Intervention |