FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR
MDR report key: 6108214
·
Received November 16, 2016
Report
- Report Number
- 2938836-2016-14334
- Event Type
- Malfunction
- Date Received
- November 16, 2016
- Date of Event
- October 25, 2016
- Report Date
- October 26, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Removal / Correction Number
- Z-2572-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER FEELING VIBRATORY PATIENT NOTIFICATION ALERT, AN ALERT DUE TO A LONG CAPACITOR MAINTENANCE CHARGE TIME WAS NOTED. MANUAL CAPM WAS PERFORMED AND NORMAL CHARGE TIME WAS NOTED. PATIENT'S DEVICE WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756018 | ELLIPSE VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD1411-36C | 4310455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |