FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 3220398
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04671
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 10, 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 Location
- MN
- 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
THE REPORTED FIELD EVENT OF HIGH, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE MEASUREMENTS WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF PROGRAMMER PRINTOUTS. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE OBSERVED. THE CAUSE OF THE IMPEDANCE ANOMALY REMAINS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL EMERGENCY ROOM, DUE TO OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE MEASUREMENT. THE PATIENT RECEIVED WHAT APPEARS TO BE APPROPRIATE HIGH VOLTAGE THERAPY FOR A TRUE VENTRICULAR ARRHYTHMIA. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321014 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | (B)(4) |