FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR, DF4 CONNECTOR
MDR report key: 3781701
·
Received April 30, 2014
Report
- Report Number
- 2938836-2014-10049
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- February 26, 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. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF AN INABILITY TO FULLY INSERT THE ATRIAL LEAD IN THE HEADER WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION IDENTIFIED EXCESS EPOXY ON THE ATRIAL RING CONTACT SPRING. IT IS BELIEVED THAT THE EXCESS EPOXY PREVENTED THE LEAD FROM FULLY INSERTING INTO THE HEADER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WOULD NOT ACCEPT A LEAD INTO THE ATRIAL HEADER PORT. THE DEVICE WAS NOT IMPLANTED WAS REPLACED. NO CHANGE IN PATIENT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260373 | ELLIPSE DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |