FDA Adverse Event
Injury
Summary report: N
ATLAS II DR
MDR report key: 3210457
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03543
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 20, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE RESETTLED AFTER AN EXTERNAL DEFIBRILLATION. OVER THE PRIOR TWO DAYS, A LARGE NUMBER OF APPROPRIATE SHOCKS FOR VT/VF WERE RECORDED. EXTENDED CHARGE TIMES AND OVERSENSING OF VENTRICULAR NOISE WAS ALSO OBSERVED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310436 | ATLAS II DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-265 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |