FDA Adverse Event
Malfunction
Summary report: N
OPTISENSE LEAD
MDR report key: 6049539
·
Received October 22, 2016
Report
- Report Number
- 2938836-2016-13167
- Event Type
- Malfunction
- Date Received
- October 22, 2016
- Date of Event
- September 23, 2016
- Report Date
- September 23, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC WITH STORED EPISODES OF AUTO MODE SWITCH DUE TO ATRIAL LEAD NOISE. THE NOISE WAS REPRODUCIBLE WITH DEEP INSPIRATIONS AND COUGHING. REVIEW OF THE STRIPS NOTED OVERSENSING OF LEAD NOISE. PROGRAMMING CHANGE WAS RECOMMENDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700699 | OPTISENSE LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1999/46 | 4461730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |