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

Model Number 350973

Device Problem Pacing Inadequately (1442)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2009 and remains implanted at the time.A call was placed to technical services on 10/20/2016 stating that noted atrial intrinsic amplitude measured at 0.2-0.3 mv, impedance stable and put sensitivity down to 0.15 mv, threshold in the a is 5 v at 2 ms, on the egm has biv pacing but expected to see ap if no as is being seen.The physician was dr.(b)(6) at (b)(6) hopital in (b)(6) ca.No other information is availale.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: 17531606
• MDR Text Key: 321380343
• Report Number: MW5138519
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 350973
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1