FDA Adverse Event
Death
Summary report: N
ATLAS II PLUS HF CRT-D
MDR report key: 4240760
·
Received November 10, 2014
Report
- Report Number
- 2938836-2014-17721
- Event Type
- Death
- Date Received
- November 10, 2014
- Date of Event
- October 12, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
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 THE PATIENT WAS BROUGHT TO THE HOSPITAL AFTER BEING SHOCKED AT HOME. SEVERAL SHOCKS WERE DELIVERED DURING TRANSPORT TO THE HOSPITAL. THE PATIENT WAS IN VT. AT THE HOSPITAL, THE PATIENT WAS RESCUED WITH EXTERNAL DEFIBRILLATION AND THE HEART RATE RETURNED TO SINUS RHYTHM. THE DEVICE WAS FOUND TO BE IN END OF LIFE AND COULD NOT BE INTERROGATED. LATER THAT DAY, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723910 | ATLAS II PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | V-367 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |