FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX XL DR
MDR report key: 4190078
·
Received January 11, 2014
Report
- Report Number
- 2017865-2014-02252
- Event Type
- Malfunction
- Date Received
- January 11, 2014
- Date of Event
- May 9, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 DURING A FOLLOW UP THE DEVICE PRESENTED IN BACKUP MODE. A USER DOWNLOAD COULD NOT BE ATTEMPTED SO THE DEVICE WAS SCHEDULED TO BE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21577 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC., CRMD | 5386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |