FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 3220399
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04668
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- March 19, 2013
- Report Date
- April 8, 2013
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER AND MAUDE REPORT (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE FACILITY IN CARDIAC ARREST AND IN VF. EXTERNAL DEFIBRILLATION WAS ADMINISTERED BY EMS. UPON INTERROGATION, IT WAS NOTED THAT THE DEVICE FAILED TO DELIVER HV THERAPY WITH LOW IMPEDANCE. THE PATIENT WAS ADMITTED TO THE ICU. THE LEAD AND ICD WERE LATER EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320563 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 1580/65, (B)(4) |