FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 1831067
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03633
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 22, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- 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
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. MULTIPLE PROGRAMMERS HAD BEEN USED TO ATTEMPT INTERROGATION. THE BATTERY VOLTAGE IN (B)(6) 2009 WAS 2.90V. THE PATIENT HAD NOT RECEIVED ANY SHOCKS SINCE THEN AND THE PATIENT HARDLY EVER USED PACING. THE DEVICE WAS EXPLANTED AND REPLACED.
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 | 59 YR | Required Intervention |