FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE XL LV
MDR report key: 1223837
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03451
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMAP030054
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- ID
- 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 PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION ON THE LEFT SIDE WITH THE LEFT VENTRICULAR LEAD OUTPUT AT 1.5 V, 0.5 MS, IN BOTH THE BIPOLAR AND THE LEFT VENTRICULAR TIP TO RIGHT VENTRICULAR COIL CONFIGURATIONS. WHEN PROGRAMMED TO THE LEFT VENTRICULAR RING TO RIGHT VEN- TRICULAR COIL CONFIGURATION, THERE WAS NO CAPTURE AT HIGH OUTPUTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE XL LV | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1058T/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |