FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS HF CRT-D
MDR report key: 2242416
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06653
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- July 5, 2011
- 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 Location
- AL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ANOMALY OBSERVED IN THE FIELD WAS CONFIRMED. ANALYSIS FOUND ANOMALOUS COMPONENTS WITHIN THE HYBRID. THE DEVICE WAS TESTED ON THE BENCH AND IN THE AUTOMATED SYSTEM; NO ANOMALIES WERE FOUND. IT IS SUSPECTED THAT A LEAD ANOMALY WAS THE CAUSE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT RECEIVED AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE. DEVICE WOULD NO LONGER DELIVER THERAPY. POSSIBLE LEAD ANOMALY SUSPECTED. SYSTEM EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-366 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | (B)(4) |