FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR
MDR report key: 3943822
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13511
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 3, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC WITH NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421717 | ELLIPSE VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1311-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |