FDA Adverse Event
Malfunction
Summary report: N
QUARTET LEAD SMALL-S, 86 CM
MDR report key: 11314960
·
Received February 11, 2021
Report
- Report Number
- 2017865-2021-05950
- Event Type
- Malfunction
- Date Received
- February 11, 2021
- Date of Event
- January 21, 2021
- Report Date
- February 28, 2021
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- UDI-DI
- 05414734510158
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED EVENTS OF INADEQUATE CAPTURE THRESHOLD WAS NOT CONFIRMED. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. THE PHYSICIAN PLACED THE LEFT VENTRICULAR LEAD IN MULTIPLE TARGET VESSELS, HOWEVER, THE PHYSICIAN WAS DISPLEASED WITH THE SHORT QLV TIMING AND THE PROXIMAL PACING OPTIONS. THEREFORE, THE PHYSICIAN EXCHANGED THE LEAD DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210030 | QUARTET LEAD SMALL-S, 86 CM | PERMANENT PACEMAKER ELECTRODE | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1456Q/86 | A000093414 | 05414734510158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |