FDA Adverse Event
Malfunction
Summary report: N
ATLAS II VR
MDR report key: 3880546
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03438
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- January 18, 2013
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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. COMPANY REP.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE REPORTED SOFTWARE RESET UPON INTERROGATION. THE PT DID NOT RECEIVE A SHOCK. DEVICE IMAGINE WAS DOWNLOADED SUCCESSFULLY AFTER SEVERAL ATTEMPTS. TECHNICAL SERVICES DISCUSSED DOWNLOADING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31267 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL INC., CRMD | V-168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |