FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE ST VR, DF-4 CONNECTOR
MDR report key: 4153472
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16381
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 24, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT NON-SUSTAINED OVERSENSING EPISODES DUE TO MYOPOTENTIAL OVERSENSING WERE OBSERVED VIA EGMS. PROGRAMMING CHANGES WERE MADE. PATIENT WAS FINE.
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO NON-SUSTAINED RV OVERSENSING EPISODES WERE OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED. PATIENT IS BEING MONITORED REMOTELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630957 | ELLIPSE ST VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1277-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |