FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADK XL DR
MDR report key: 4149250
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-06050
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- September 16, 2011
- 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
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 WAS IN CLINIC FOR FOLLOW-UP AND THE DEVICE PRESENTED IN BVVI. IMPEDANCE WAS FOUND TO BE TOO HIGH FOR DOWNLOAD. THE DEVICE WILL BE ELECTIVELY REPLACED DUE TO NEARING ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31674 | IDENTITY ADK XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | 5386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR |