FDA Adverse Event
Malfunction
Summary report: N
ATLAS II DR
MDR report key: 3890548
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04471
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- November 2, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PT PRESENTED IN CLINIC DURING FOLLOW UP WITH A DEVICE THAT WAS POST SENSED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PT DID NOT RECEIVE THERAPY. REPROGRAMMING WAS DISCUSSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30227 | ATLAS II DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL INC., CRMD | V-265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |