FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 2242403
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06645
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- July 6, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. THE CAUSE OF THE LOW BATTERY VOLTAGE WAS DUE TO HIGH CURRENT DRAW FROM AN ANOMALOUS INTEGRATED CIRCUIT COMPONENT WITHIN THE HYBRID ASSEMBLY.
Description of Event or Problem · 1
THE PATIENT PRESENTED TO THE CLINIC AFTER NOT FEELING WELL. IT WAS NOTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-340 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |