FDA Adverse Event
Malfunction
Summary report: N
ANTHEM RF
MDR report key: 4143144
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05653
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- May 15, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DXY
- 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. INITIAL REPORTER: COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE DEVICE WAS EXPOSED TO EXTERNAL DEFIBRILLATION IT DISPLAYED ERI AND EOS INDICATORS THAT WERE FALSE. THE INDICATORS WERE CLEARED, AND A FIRMWARE DOWNLOAD RESOLVED THE ISSUE. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31688 | ANTHEM RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, CRMD | PM3210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |