FDA Adverse Event
Malfunction
Summary report: N
FRONTIER
MDR report key: 4143205
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05691
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- February 28, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- NKE
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR ROUTINE FOLLOW UP. THE PULSE GENERATOR EXHIBITED INAPPROPRIATE MEASURED DATA. THE DEVICE WAS REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31645 | FRONTIER | IMPLANTABLE PACEMAKER PULSE GENERATOR | NKE | ST. JUDE MEDICAL, INC. CRMD | 5508L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |