FDA Adverse Event
Death
Summary report: N
ELLIPSE DR ICD
MDR report key: 6145479
·
Received December 5, 2016
Report
- Report Number
- 2938836-2016-15335
- Event Type
- Death
- Date Received
- December 5, 2016
- Date of Event
- November 5, 2016
- Report Date
- November 7, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. A REMOTE TRANSMISSION SHOWED 3 VT/VF EPISODES. THE FIRST EPISODE SHOWED THAT THE PATIENT WENT INTO VT/VF THAT TRIGGERED APPROPRIATE VF THERAPY. ALL THERAPIES WERE EXHAUSTED AND DID NOT CONVERT THE RHYTHM. THE DEVICE RESPONDED APPROPRIATELY AS-PROGRAMMED. CPR WAS ADMINISTERED TO REVIVE HIM BUT WAS UNSUCCESSFUL. NO COMPLAINT WAS MADE AGAINST THE DEVICE BY THE PATIENT'S FAMILY OR BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795541 | ELLIPSE DR ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2411-36C | A000010804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death |