FDA Adverse Event
Injury
Summary report: N
ELLIPSE VR ICD
MDR report key: 5202281
·
Received November 4, 2015
Report
- Report Number
- 2938836-2015-30430
- Event Type
- Injury
- Date Received
- November 4, 2015
- Report Date
- September 3, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS SHOCKED WHILE DRIVING AND CONTINUED TO BE SHOCKED FOR TWO MONTHS. PATIENT STATED THAT HER MEDICATIONS WERE CONSTANTLY BEING CHANGES AT THIS TIME. IT WAS ALSO NOTED THAT THE PATIENT NOTIFIER HAD INDICATED THAT THE DEVICE WAS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732120 | ELLIPSE VR ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD1311-36Q | 3845226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |