FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 3910922
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-13003
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- May 29, 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF AN INABILITY TO INSERT THE ATRIAL LEAD WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION IDENTIFIED EXCESS EPOXY IN 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 ATRIAL LEAD COULD NOT BE INSERTED INTO THE HEADER. THE DEVICE WAS REPLACED. PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387402 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2311-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |