FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 3920917
·
Received July 8, 2014
Report
- Report Number
- 2938836-2014-13320
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- April 10, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 PATIENT RECEIVED A TRANSMISSION FOR BACK UP VVI VIA MERLIN.NET. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE BACKUP VVI TRANSMISSION WAS INAPPROPRIATE. THE DEVICE WAS NOT FOUND IN BACK UP VVI. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IN-CLINIC FOLLOW-UP, SESSION RECORDS SHOWED A DEVICE PARAMETER ERROR WAS DETECTED PROBABLE DUE TO A TELEMETRY ERROR. REPROGRAMMING THE DEVICE TO RESOLVE THE ISSUE WAS RECOMMENDED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398369 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2377-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |