FDA Adverse Event
Malfunction
Summary report: N
FORTIFY DR
MDR report key: 1954770
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00487
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 11, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED ASYPTOMATIC TO THE CLINIC DUE TO A VIBRATORY ALERT. THE HIGH VOLTAGE LEAD IMPEDANCE WAS OUT OF RANGE. POSSIBLE SVC CONNECTOR SETSCREW LOOSE OR BAD CONNECTION. THE PHYSICIAN OPTED TO TURN THE SVC COIL OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORTIFY DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2231-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | 1580/65 (B)(4) |