FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 3903721
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12742
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- April 16, 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO CLINIC AFTER AN ALERT FOR VENTRICULAR OVERSENSING WAS RECEIVED VIA A MERLIN.NET TRANSMISSION. FREQUENT CROSSTALK ON THE VENTRICULAR CHANNEL AFTER ATRIAL PACING WAS NOTED. PROGRAMMING CHANGES WERE MADE BUT DID NOT RESOLVE THE ISSUE. PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
CORRECTION: OVERSENSING CALCULATION WAS ATTEMPTED, BUT WAS UNABLE TO RESOLVE THE ISSUE WITH ANY COMBINATION OF ADJUSTMENTS. THE DECISION WAS MADE TO MONITOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380454 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2311-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |