FDA Adverse Event
Injury
Summary report: N
ACCENT DR
MDR report key: 4191740
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04788
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- July 31, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 1
IT WS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE POCKET AND THE PULSE GENERATOR HAD MIGRATED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28343 | ACCENT DR | IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Required Intervention |