FDA Adverse Event
Death
Summary report: N
ATLAS PLUS DR
MDR report key: 2231691
·
Received September 1, 2011
Report
- Report Number
- 2017865-2011-05350
- Event Type
- Death
- Date Received
- September 1, 2011
- Date of Event
- January 5, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THIS IS TO CORRECT BRAND NAME, COMMON NAME, PRODUCT CODE AND PMA NUMBER.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PATIENTS DEATH WAS NOT DEVICE RELATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. NO KNOWN CAUSE WAS REPORTED OR DEVICE ISSUES. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death | (B)(4) |