FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 4210695
·
Received October 29, 2014
Report
- Report Number
- 2938836-2014-17203
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Date of Event
- September 16, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 A MERLIN.NET TRANSMISSION SHOWED THE DEVICE IN BACKUP VVI MODE. THE PATIENT WAS ASYMPTOMATIC. A DEVICE CODE DOWNLOADED WAS PERFORMED SUCCESSFULLY TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692875 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |