FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS VR
MDR report key: 1955223
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00555
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- August 18, 2010
- 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
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ATTORNEY.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF INAPPROPRIATE THERAPIES WAS CONFIRMED AFTER REVIEW OF THE STORED ELECTROGRAMS. THE DEVICE TESTED NORMALLY IN THE LABORATORY AND ALL SPECIFICATIONS WERE MET. THE CAUSE OF THE EVENT REMAINS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATIONS WITH THE REMOTE TRANSMITTER IN (B)(6) 2010, DURING A REMOTE TRANSMISSION VIA PHONE. ON (B)(6) 2010, DURING ANOTHER REMOTE TRANSMISSION, THE ICD ENGAGED AND DELIVERED MULTIPLE CHARGES OVER A 35 MINUTE PERIOD. THE PATIENT PRESENTED TO THE HOSPITAL AND THE ICD WAS DISABLED. THE PATIENT IS BEING MONITORED.
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 | 61 YR | (B)(4) |