FDA Adverse Event
Injury
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 2083686
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-02543
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- February 16, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE EVEN AT 7.5 V, 1.5 MS. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL. THE LEAD WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1156T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |