FDA Adverse Event
Other
Summary report: N
MERLIN PROGRAMMER
MDR report key: 3646003
·
Received February 25, 2014
Report
- Report Number
- 2017865-2014-07596
- Event Type
- Other
- Date Received
- February 25, 2014
- Date of Event
- March 28, 2013
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- KRG
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
ALL INFO 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 WHEN TRYING TO PROGRAM THE DEVICE WHILE THERAPIES WERE ENABLED, THE PROGRAMMER SHOWED A DIMMED AND GREYED OUT SCREEN. THE ISSUE WAS RESOLVED WITH TECHNICAL SUPPORT, BY SWITCHING OFF THERAPIES AND REPROGRAMMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115191 | MERLIN PROGRAMMER | PACEMAKER PROGRAMMER | KRG | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION | 3650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |