FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 6015857
·
Received October 10, 2016
Report
- Report Number
- 2938836-2016-12546
- Event Type
- Malfunction
- Date Received
- October 10, 2016
- Date of Event
- September 20, 2016
- Report Date
- September 20, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
THE REPORTED ATRIAL SENSING ANOMALY WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND FOREIGN MATERIAL WAS FOUND NEAR SENSING CAPACITORS ON THE HYBRID. IT IS BELIEVED THE FOREIGN MATERIAL CAUSED THE FIELD EVENT.
Description of Event or Problem · 1
IT WAS REPORTED DURING IMPLANTATION, INAPPROPRIATE AUTO MODE SWITCHING EPISODES WERE OBSERVED DUE TO NOISE ON THE ATRIAL CHANNEL. NOISE WAS STILL PRESENT EACH TIME THE LEAD WAS REINSERTED INTO THE DEVICE HEADER. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED INSTEAD. THE PATIENT TOLERATED THE PROCEDURE AND WILL BE FOLLOWED-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 665467 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2411-36Q | A000013565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |