FDA Adverse Event
Injury
Summary report: N
FORTIFY VR
MDR report key: 2242948
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06533
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 15, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.
Description of Event or Problem · 1
IT WAS REPORTED THAT INFECTION WAS SUSPECTED DURING SCHEDULED POCKET REVISION. THE PATIENT DID NOT HAVE (B)(6). THE DEVICE UNDERWENT STERILIZATION AND WAS CONNECTED TO A NEW LEAD AND INTERROGATED. THE DEVICE WAS FOUND IN BACK UP MODE. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORTIFY VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1231-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | (B)(4) |