FDA Adverse Event
Injury
Summary report: N
ACCENT SR RF OUS
MDR report key: 4191717
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04787
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- November 7, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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. THE REPORTED FIELD EVENT OF NOISE WAS NOT CONFIRMED. ELECTRICAL ANALYSIS EXHIBITED NORMAL CHARACTERISTICS. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED NOISE ON EGMS. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34092 | ACCENT SR RF OUS | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC., CRMD | PM1210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | 2088TC/52 BER014267 |