FDA Adverse Event
Injury
Summary report: N
INTEGRITY AFK DR
MDR report key: 3925465
·
Received January 15, 2014
Report
- Report Number
- 2017865-2014-08807
- Event Type
- Injury
- Date Received
- January 15, 2014
- Date of Event
- April 14, 2011
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
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 A PATIENT WITH FATIGUE PRESENTED IN CLINIC FOR FOLLOW UP. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38361 | INTEGRITY AFK DR | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC. CRMD | 5342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention |