FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 1073486
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02265
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- December 24, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- 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 ANALYSIS FOUND THE RETURNED ICD TO BE ABOVE ERI. VISUAL INSPECTION REVEALED NORMAL DEVICE CHARACTERISTICS. NO ANOMALOUS BEHAVIOR WAS OBSERVED.
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED WHEN INFECTION DUE TO EROSION WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |