FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 4760362
·
Received May 8, 2015
Report
- Report Number
- 2938836-2015-04665
- Event Type
- Injury
- Date Received
- May 8, 2015
- Date of Event
- March 20, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
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 HIGH, OUT OF RANGE PACING LEAD IMPEDANCE WAS OBSERVED WHILE THE PATIENT POST-PROCEDURE. IT WAS NOTED THAT THE LEAD WAS NOT COMPLETELY SCREWED IN. THE LEAD WAS RECONNECTED PROPERLY. THE PATIENT WAS FINE POST-PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH, OUT OF RANGE PACING LEAD IMPEDANCE WAS OBSERVED PRIOR TO PATIENT BEING DISCHARGED. POCKET WAS RE-OPENED TO VERIFY CONNECTION, AND IT WAS NOTED THAT THE LEAD WAS NOT COMPLETELY SCREWED IN. THE LEAD WAS RECONNECTED PROPERLY. THE PATIENT WAS FINE POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302756 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2377-36QC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |