FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR
MDR report key: 3210544
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03404
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 15, 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.(B)(4).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE NON-SUSTAINED LEAD NOISE EPISODES WERE NOTED. INTERMITTENT VENTRICULAR EVENTS FELL INTO THE VENTRICULAR BLANKING PERIOD AFTER ATRIAL PACING. REPROGRAMMING WAS RECOMMENDED. THE PATIENT HA D AN INFECTION AND THE SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311374 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2311-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | (B)(4) |