FDA Adverse Event
Injury
Summary report: N
QUICKSITE LV
MDR report key: 1073426
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02210
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO OVERSENSING. THE PHYSICIAN ELECTED TO OPEN THE POCKET AND REALIZED THAT THE LEADS WERE REVERSED IN THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEADS WERE SUCCESSFULLY REPOSITIONED IN THE APPROPRIATE CONNECTOR PORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056K/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |