MAUDE Adverse Event Report: BIOTRONIK TESTER, PACEMAKER ELECTRODE FUNCTION

Model Number ERA300B

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2016

Event Type  malfunction  

Event Description

It was noted on (b)(6) 2016 that there was malfunctioning of the system with low internal battery capacity.During system boot a malfunctioning printer was detected, and an error message was shown.The physician was dr.(b)(6) at (b)(6) in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TESTER, PACEMAKER ELECTRODE FUNCTION
• Type of Device: TESTER, PACEMAKER ELECTRODE FUNCTION
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17534965
• MDR Text Key: 321433835
• Report Number: MW5141865
• Device Sequence Number: 1
• Product Code: DTA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ERA300B
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1