FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS DR
MDR report key: 3220050
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04686
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 15, 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
- NY
- 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
CORRECTION: IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP. UPON INTERROGATION, THE DEVICE WAS IN BVVI, WITH NO HV THERAPY AVAILABLE. DISABLING THE HV THERAPY HAD BEEN DISCUSSED PREVIOUSLY BECAUSE OF THE PATIENTS FAILING HEALTH. NO FURTHER DEVICE FOLLOW-UP WAS NEEDED. NO DEVICE EXPLANT WOULD BE SCHEDULED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP. UPON INTERROGATION, THE DEVICE WAS IN BVVI, WITH NO HV THERAPY AVAILABLE. THE PATIENT WILL BE SCHEDULED FOR DEVICE REPLACEMENT AND THE DEVICE WILL BE SENT BACK FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321313 | ATLAS PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |