FDA Adverse Event
Malfunction
Summary report: N
OPTISENSE
MDR report key: 4231320
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18111
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- August 18, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).
Description of Event or Problem · 1
NEW INFORMATION INDICATED THAT THE LEAD EXHIBITED HIGH IMPEDANCE AND NOISE. THE NOISE COULD BE REPRODUCED THROUGH ISOMETRICS. THE PATIENT WAS ASYMPTOMATIC. NO INTERVENTION WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCE. NO INTERVENTION HAD BEEN REPORTED. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714447 | OPTISENSE | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1999/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |