FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 1050471
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01452
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- November 1, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- 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 WAS SEEN IN CLINIC AFTER HAVING PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF FLUTTERING IN THE CHEST. THE PATIENT NO LONGER FELT THE FLUTTERING, BUT INTERROGATION OF THE PULSE GENERATOR INDICA- TED THAT THE LEFT VENTRICULAR LEAD EXHIBITED NO CAPTURE AT 6.75 V. X-RAY REVEALED THAT THE LEAD APPEARED TO HAVE RETRACTED INTO THE SUPERIOR VENA CAVA. ABOUT THREE WEEKS LATER, THE PATIENT UNDERWENT A HEART TRANSPLANT PROCEDURE.
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 |