FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 4031759
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14748
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- July 21, 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
- NURSE
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 AN ALERT FOR CHARGE TIME LIMIT REACHED WAS RECEIVED VIA REMOTE TRANSMISSION. UPON REVIEW, THE LONG CHARGE TIME WAS CONFIRMED. DUE TO THE PATIENTS POOR HEALTH CONDITION, DEVICE REPLACEMENT WILL NOT BE PERFORMED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509361 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |