FDA Adverse Event
Malfunction
Summary report: N
IDENTITY XL DR
MDR report key: 4140329
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05907
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- January 21, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 GOOD FORWARD. INITIAL REPORTER: TECH SERV SPECIALIST.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT WITH FATIGUE PRESENTED IN CLINIC FOR A FOLLOW UP. THE DEVICE EXHIBITED BACKUP VVI OPERATION. DEVICE REPLACEMENT WAS SCHEDULED ELECTIVELY DUE TO APPROACHING ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29156 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC. CRMD | 5376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |