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

Model Number 346366

Device Problems High impedance (1291); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2013

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2010 and was capped on (b)(6) 2013 due to pacing not delivered when required and high pace impedance greater than 2000 ohms confirmed through analyzer.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).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: 17523204
• MDR Text Key: 321146687
• Report Number: MW5130152
• 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: 12/17/2013

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: 346366
• Patient Sequence Number: 1