FDA Adverse Event
Malfunction
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 6211041
·
Received December 28, 2016
Report
- Report Number
- 2017865-2016-08049
- Event Type
- Malfunction
- Date Received
- December 28, 2016
- Date of Event
- November 29, 2016
- Report Date
- November 29, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL, NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A DEVICE CHANGE OUT, THE PHYSICIAN FOUND IT DIFFICULT TO IMPLANT THE LEFT VENTRICULAR LEAD DUE TO DISLODGEMENT, THE PATIENT HAD SMALLER THAN AVERAGE SINUS VESSELS. THE LEAD WAS NOT USED AND A NEW LEAD WAS PLACED SUCCESSFULLY. THE PATIENT WAS STABLE POST-PROCEDURE AND DID NOT SUFFER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861796 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1258T/86 | A000029273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |