FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 1895845
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04755
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 9, 2010
- 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
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ANALYSIS CONFIRMED THE REPORTED OUTPUT ANOMALY. AN ARC MARK WAS OBSERVED ON THE ICD CAN. FURTHER EVALUATION OF THE ARC MARKS INDICATED THE PRESENCE OF LEAD MATERIAL. THE DAMAGE FOUND IS CONSISTENT WITH THAT CAUSED BY ARCING BETWEEN THE HV CONDUCTOR AND THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE SHOWED AN ALERT STATING OUTPUT CIRCUIT DAMAGE DURING A HV INTEGRITY CHECK. THE IMPEDANCE TRENDS WERE CLEARED ON THE DEVICE. WHEN THE IMPEDANCE TESTING WAS INITIATED THE SAME ALERT APPEARED. NO DAMAGE WAS SEEN ON THE DEVICE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | (B)(4) (B)(4) |