FDA Adverse Event
Injury
Summary report: N
QUICKFLEX LV LEAD
MDR report key: 4962009
·
Received August 3, 2015
Report
- Report Number
- 2017865-2015-27392
- Event Type
- Injury
- Date Received
- August 3, 2015
- Date of Event
- July 20, 2015
- Report Date
- July 20, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP AND UPON INTERROGATION, THE LEFT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND LOSS OF CAPTURE. THE PATIENT ALSO EXPERIENCED DIAPHRAGMATIC STIMULATION. NO INTERVENTION WAS REPORTED AND THE PATIENT WOULD BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION INDICATED THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2015. THE PATIENT WAS SYMPTOMATIC DUE TO LOSS OF BI-VENTRICULAR PACING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504930 | QUICKFLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1156T/86 | 2821515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |