U.S. flag An official website of the United States government
  1. Home
  2. Combination Products
  3. Guidance & Regulatory Information
  4. eMDR Example Scenario. PMA-approved steroid-eluting lead
  1. Guidance & Regulatory Information

eMDR Example Scenario. PMA-approved steroid-eluting lead

The following scenario is intended solely to illustrate how to provide combination product information identified in section V.B.2 of the Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff in the data fields of the eMDR reporting system. The scenario described below is not intended to provide a comprehensive representation of all information that may be appropriate to include in ICSRs or how to present it, for a given event, report type, or product type, nor to identify all reports that may be required in relation to the events described.

Scenario. The Combination Product Applicant receives information that patient J. Doe had a serious infection that was caused by contamination of the implanted combination product. The applicant submits a serious injury report (see 21 CFR 4.102(b) and 803.50). The product, Implant C, has a coating containing the active ingredient, Active C. The product code for the device is DXY (Implantable Pacemaker Pulse Generator). 

Data Elements.The applicant reviews the Device Problem Codes and identifies “Item Contaminated During Manufacturing Or Shipping FDA 2969 Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use” as appropriate for the contamination. 

The applicant reviews the Patient Problem Codes and identifies “Infection FDA 1930” as appropriate for the adverse event.

In addition to other content appropriate for the report type, the Combination Product Applicant completes the following elements in the ICSR data fields for eMDR as indicated below:

Type of Information (see section V.B.2 of the PMSR guidance) Form 3500A Identifier eMDR Descriptor  Element Value
Combination Product Identifier Combination Product [Box G.5] Combination Product Yes
Report Type(s)  Type of Report [Box G.7] Type_of_Report 30-day Report

Type of Reportable Event [Box H.1]
Type_of_Reportable_Event Serious Injury
Patient Identifier  Patient Identifier Patient Identifier [Box A.1] Patient Identifier J. Doe
Suspect Medical Device Brand Name [Box D.1]  Brand_Name Implant C
Common Device Name [Box D.2] Common Device Name Implantable Pacemaker Pulse Generator
Procode [Box D.2b] Device Procode DXY
Suspect Drug Product Name [Box C.1] Suspect Product(s) Active C
Adverse Event Coding Patient Code
[Box H.6] 
Patient_Problem_Code 1930
Device Problem Code Code Device Code
[Box H.6]
Device_Problem_Code 2969





Back to Top