FDA Adverse Event
Malfunction
Summary report: N
MICRONY K SR
MDR report key: 3927096
·
Received January 15, 2014
Report
- Report Number
- 2017865-2014-08707
- Event Type
- Malfunction
- Date Received
- January 15, 2014
- Date of Event
- July 13, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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 PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP. UPON INTERROGATION THE PULSE GENERATOR DISPLAYED AN ERROR MESSAGE INFORMING THE USER THAT THE DATA COULD NOT BE READ. THE DEVICE WAS SCHEDULED TO BE EXPLANTED DUE TO APPROACHING ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40094 | MICRONY K SR | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC. CRMD | 2535K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |