FDA Adverse Event
Malfunction
Summary report: N
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 6391794
·
Received March 9, 2017
Report
- Report Number
- 2938836-2017-17911
- Event Type
- Malfunction
- Date Received
- March 9, 2017
- Date of Event
- November 17, 2016
- Report Date
- December 21, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THROUGH REMOTE TRANSMISSION THAT LOW, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES AND DTF TESTING WAS RECOMMENDED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173925 | OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | LDA220Q/58 | A000014470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |