FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 3090024
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01291
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 7, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WHILE IN THE INTENSIVE CARE UNIT, RECEIVED MULTIPLE UNSUCCESSFUL SHOCKS FROM THE ICD. AN EXTERNAL DEFIBRILLATOR WAS USED TO RESCUE THE PATIENT. THE ICD WAS LATER FOUND IN BACKUP VVI MODE. IT WAS RECOMMENDED TO EXPLANT THE DEVICE. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2013, UNRELATED TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191447 | ATLAS PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-341 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |