FDA Adverse Event
Death
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 6147679
·
Received December 6, 2016
Report
- Report Number
- 2938836-2016-15403
- Event Type
- Death
- Date Received
- December 6, 2016
- Date of Event
- October 17, 2016
- Report Date
- November 15, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED FOR ANALYSIS IN THREE SEGMENTS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. OTHER CONDITIONS LISTED ARE CHRONIC RENAL DISEASE, HYPERTENSION, AND ATRIAL FIBRILLATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800170 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 7121/65 | 2703575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Death | 1888TC/52, BCG35533| 2207-36, 505721 |