FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS HF CRT-D
MDR report key: 1073528
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02422
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 1, 2008
- 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
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE REVEALED THAT A POWER-ON RESET OCCURRED DURING HV THERAPY DELIVERY. THE DEVICE WAS TESTED ON THE BENCH AND A DAMAGED OUTPUT TRANSISTOR WAS OBSERVED. THE DAMAGE WAS CAUSED BY DELIVERY OF HV THERAPY INTO A LOW IMPEDANCE OUTPUT. THE CAUSE OF THE LOW IMPEDANCE OUTPUT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WENT INTO HARDWARE BACKUP VVI MODE. THE DEVICE WAS 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 | 81 YR | Required Intervention |