FDA Adverse Event
Death
Summary report: N
OPTISURE ACTIVE FIXATION
MDR report key: 6098288
·
Received November 13, 2016
Report
- Report Number
- 2938836-2016-14127
- Event Type
- Death
- Date Received
- November 13, 2016
- Date of Event
- October 15, 2016
- Report Date
- October 18, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
A PARTIAL LEAD MEASURING 25.7 CM FROM THE CONNECTOR PIN WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS 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 |
|---|---|---|---|---|---|---|---|
| 749374 | OPTISURE ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | LDA220/65 | 4785339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | (B)(4)| (B)(4) |