FDA Adverse Event
Malfunction
Summary report: N
IDENTITY XL DR
MDR report key: 4190085
·
Received January 11, 2014
Report
- Report Number
- 2017865-2014-02259
- Event Type
- Malfunction
- Date Received
- January 11, 2014
- Date of Event
- May 22, 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
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 IN CLINIC FOR FOLLOW UP. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED ON (B)(6) 2012 DUE TO NORMAL ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21400 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC., CRMD | 5376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |