MAUDE Adverse Event Report: BIOTRONIK PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 362702

Device Problems Failure to Capture (1081); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2016

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2016 and was repositioned on (b)(6) 2016 due to failure to capture.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17534360
• MDR Text Key: 321520192
• Report Number: MW5141262
• Device Sequence Number: 1
• Product Code: NVZ
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 362702
• Patient Sequence Number: 1