FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 4190192
·
Received January 11, 2014
Report
- Report Number
- 2017865-2014-02204
- Event Type
- Malfunction
- Date Received
- January 11, 2014
- Date of Event
- September 12, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH THRESHOLD. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21533 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, CRMD | 1056T/86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |