FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR
MDR report key: 3210615
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03363
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 4, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF HIGH PACING LEAD IMPEDANCE MEASUREMENTS COULD NOT BE CONFIRMED. REVIEW OF STORED ELECTROGRAMS NOTED NOISE AND A DISTORTED SIGNAL WHICH OCCURRED IN THE FIELD. THE CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CLARIFICATION OF EVENT: THE EVENT OCCURRED AT IMPLANT AND THE DEVICE WAS NEVER IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE CHANGE OUT, HIGH PACING LEAD IMPEDANCE WAS OBSERVED. THE DEVICE WAS UNABLE TO MEASURE HIGH VOLTAGE LEAD IMPEDANCE. THE DEVICE WAS UNABLE TO INDUCE FIBRILLATION DURING DFT TESTING. THE DEVICE SHOWED NO VISIBLE ANOMALIES. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309393 | ELLIPSE VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1311-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | 7120/60, (B)(4) |