FDA Adverse Event
Injury
Summary report: N
FORTIFY DR, DF-4 CONNECTOR
MDR report key: 2242613
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06563
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 14, 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
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED VIA REVIEW OF DEVICE MEMORY INFORMATION. VISUAL ANALYSIS FOUND ONE OF THE HV CAPACITORS TO BE SWOLLEN, INDICATIVE OF A CAPACITOR ANOMALY. THE HV CAPACITORS WERE REPLACED AND THE DEVICE CHARGED NORMALLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE'S CHARGE TIME WAS LONGER THAN 30 SECONDS. PRIOR CAP MAINTENANCE ATTEMPTS WERE UNSUCCESSFUL. PATIENT REPORTED THAT THE DEVICE WAS WARMING UP IN THE POCKET. THE DEVICE WAS EXPLANTED 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 | 29 YR | Required Intervention |