FDA Adverse Event
Injury
Summary report: N
PROMOTE ACCEL CRT-D
MDR report key: 1831092
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03614
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 12, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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.
Additional Manufacturer Narrative · 1
CONTINUED: 1258T/86, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO INFECTION AND CARDIO OBSTRUCTIVE PULMONARY DISEASE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTED THAT THE SYSTEM WAS EXPLANTED DUE TO RECURRING POCKET INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE ACCEL CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |