FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 3880487
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03472
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- August 2, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW UP, THE PHYSICIAN SAW AN OVERSENSING OF THE SAME BEAT AFTER PACING BOTH VENTRICLES. AN INTERMITTENT OVERSENSING OF T-WAVES WAS OBSERVED. THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31229 | ATLAS PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK | NIK | ST. JUDE MEDICAL INC., CRMD | V-341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |