FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 1955328
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00537
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 14, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). REVIEW OF QUALITY RECORDS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S WIFE STATED HER HUSBAND'S INCISION SITE HAD BEEN BLEEDING FOR SIX WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | (B)(4) |