FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 1896222
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04813
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- July 20, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS OF 6.25 V AT 1.0 MS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |