FDA Adverse Event
Malfunction
Summary report: N
ATLAS II PLUS DR
MDR report key: 4081398
·
Received January 14, 2014
Report
- Report Number
- 2938836-2014-06153
- Event Type
- Malfunction
- Date Received
- January 14, 2014
- Date of Event
- August 1, 2011
- 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
- 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 AND ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING SEVERAL ABORTED AND DELIVERED HV THERAPIES. EGMS REVEALED NOISE ON THE LEAD. THE ICD WAS EXPLANTED AND REPLACED. FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34939 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS | LWS | ST. JUDE MEDICAL INC., CRMD | V-268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | 1580/65, RE17004 |