FDA Adverse Event
Injury
Summary report: N
QUICKSITE XL LV
MDR report key: 1223171
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03235
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMAP030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD CORONARY ARTERY BYPASS GRAFT SURGERY. AFTER THE PROCEDURE THE LEFT VENTRICULAR LEAD IMPEDANCE HAD RISEN FROM A STEADY 780 OHMS TO GREATER THAN 2000 OHMS. LEAD EVALUATION REVEALED THAT DURING THE PROCEDURE, THE TIP HAD BEEN CUT OFF THE LEAD SO IT WAS NOT CAPTURING. THE LEAD BODY WAS EXPLANTED AND THE TIP WAS LEFT IN THE PATIENT.
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 | Required Intervention |