FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 4173892
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16646
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 25, 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
- OR, US
- Reporter Occupation
- NURSE
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 VIA MERLIN TRANSMISSION, POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL WAS OBSERVED. PHYSICIAN ELECTED NOT TO MAKE RECOMMENDED PROGRAMMING CHANGES AT THIS TIME. THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT DISPLAYED NO SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655764 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1411-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |