FDA Adverse Event
Injury
Summary report: N
LEAD
MDR report key: 6082956
·
Received November 7, 2016
Report
- Report Number
- 2938836-2016-13903
- Event Type
- Injury
- Date Received
- November 7, 2016
- Date of Event
- September 9, 2016
- Report Date
- September 9, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 1.9CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT SCREW OF THE CONNECTOR LV LEAD WAS UNABLE TO BE REMOVED AND INNER CONDUCTOR WAS BROKEN. A NEW LEAD IMPLANT PROCEDURE WAS DISCUSSED. LV LEAD WAS CAPPED ON (B)(6) 2016. DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED DUE TO ERI AND DEVICE COULD NOT BE LOOSENED. PATIENT WAS STABLE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733015 | LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1056T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | V-341 , 338554 |