FDA Adverse Event
Malfunction
Summary report: N
ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
MDR report key: 725014
·
Received June 9, 2006
Report
- Report Number
- 2938836-2006-00441
- Event Type
- Malfunction
- Date Received
- June 9, 2006
- Report Date
- April 19, 2006
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO EOL. AFTER EXPLANT, THERE WAS A CONCERN THAT THE BATTERY VOLTAGE HAD DECREASED TOO RAPIDLY FROM THE ONSET OF ERI TO EOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-240 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |