FDA Adverse Event
Death
Summary report: N
OPTISENSE
MDR report key: 6105782
·
Received November 16, 2016
Report
- Report Number
- 2938836-2016-14252
- Event Type
- Death
- Date Received
- November 16, 2016
- Date of Event
- August 2, 2016
- Report Date
- October 19, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
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 OTHER CARDIAC. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE ICD WAS PROGRAMMED OFF ON (B)(6) 2016 AND THE PATIENT WAS IN COMFORT CARE. THE CAUSE OF DEATH WAS CARDIOVASCULAR COLLAPSE DUE TO SEPTIC SHOCK. SECONDARY DIAGNOSIS WAS (STAPH AUREUS) INFECTION. THE SYSTEM WAS EVALUATED NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756764 | OPTISENSE | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1699TC/46 | 2727017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death | (B)(4)| (B)(4) |