FDA Adverse Event
Injury
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 3923443
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14725
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 15, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICLE LEAD HAD DISLODGED INTO THE CORONARY SINUS. THE LEAD HAD DISLODGED DUE TO ANATOMICAL PROBLEMS. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENTS CONDITION WAS STABLE AFTER PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400068 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1258T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |