FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 1050364
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01265
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- WA
- 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 VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE IN THE BIPOLAR CONFIGURATION. AT IMPLANT, IMPEDANCE WAS 550 OHMS AND IT SUBSEQUENLTY INCREASED TO 940 OHMS, THEN TO 1016 OHMS AND 1296 OHMS. CAPTURE THRESHOLDS WERE 1.8 V, 1.0 MS. SENSING COULD NOT BE ASSESSED. THE PATIENT BE EVALUATED AT NEXT FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |