FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 3210533
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03413
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 27, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 HIGH PACING LEAD IMPEDANCE ON THE RV LEAD WAS CONFIRMED IN THE LABORATORY. BENCH TESTING AND AN X-RAY INSPECTION IDENTIFIED A DEFORMED CONTACT SPRING IN THE DEVICE HEADER. THE ROOT CAUSE OF THE IMPEDANCE MEASUREMENT ANOMALY WAS FOUND TO BE AN INTERMITTENT VRING CONNECTION FROM THE HEADER TO THE LEAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT OUT OF RANGE RV LEAD IMPEDANCE WAS OBSERVED. UPON REVISION, THE LEAD WAS REPOSITIONED INTO HEADER MULTIPLE TIMES, LEAD IMPEDANCE MEASUREMENT REMAINED HIGH. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309987 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |