FDA Adverse Event
Death
Summary report: N
OPTISENSE
MDR report key: 6098290
·
Received November 13, 2016
Report
- Report Number
- 2938836-2016-14128
- Event Type
- Death
- Date Received
- November 13, 2016
- Date of Event
- October 15, 2016
- Report Date
- September 7, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- 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 WITH THE CONNECTOR PIN MEASURING 20.1CM WAS RETURNED FOR ANALYSIS IN ONE SEGMENT. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE 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 |
|---|---|---|---|---|---|---|---|
| 749435 | OPTISENSE | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1699TC/52 | 0002118292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | CD2357-40C, (B)(4)| LDA220/65, (B)(4) |