FDA Adverse Event
Malfunction
Summary report: N
ATLAS + HF CRT-D
MDR report key: 1050649
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01611
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- March 5, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT BECAME ASYSTOLIC UPON INTERROGATION. THE DEVICE ALSO PRESENTED WITH CROSSTALK. THE PATIENT WAS SEEN AGAIN THE FOLLOWING DAY AND NO CROSSTALK WAS OBSERVED. THE PATIENT WILL CONTINUE WITH ROUTINE FOLLOW-UP AND WILL BE MONITORED CLOSELY FOR ANY OVERSENSING ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS + HF CRT-D | NO BNCN FOUND FOR THIS DEVICE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-343 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |