FDA Adverse Event
Malfunction
Summary report: N
MICRONY K SR
MDR report key: 4083954
·
Received January 10, 2014
Report
- Report Number
- 2017865-2014-01361
- Event Type
- Malfunction
- Date Received
- January 10, 2014
- Date of Event
- June 16, 2011
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- Product Code
- DXY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS REC'D. 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 A PATIENT PRESENTED IN CLINIC FOR A F/U. DEVICE DIAGNOSTICS DATA WAS MISSING AND THERE WERE TELEMETRY INTERRUPTIONS. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19231 | MICRONY K SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 2535K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |