FDA Adverse Event
Injury
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 3923161
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14497
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- Z1483
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT CHEST X-RAY CONFIRMED THE LEFT VENTRICULAR LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THE PATIENT EXPERIENCED AN UNSPECIFIED HAEMODYNAMIC ISSUE DURING THE REVISION PROCEDURE. AS A PRECAUTION THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT AND THE CONDITION WAS STABILIZED. PATIENT WAS IN GOOD CONDITION AND DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400929 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1156T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |