FDA Adverse Event
Death
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 4153473
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16377
- Event Type
- Death
- Date Received
- October 8, 2014
- Date of Event
- June 13, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE CAUSE OF DEATH WAS ATHEROSCLEROTIC CARDIOVASCULAR DISEASE AND CARDIOMEGALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENTS WIFE STATED HE WAS SHORT OF BREATH AND THEN COLLAPSED IN THE HALLWAY. CARDIAC ARREST WAS SUSPECTED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630456 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |