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

Model Number 346369

Device Problems Failure to Capture (1081); High impedance (1291); Under-Sensing (1661); Device Dislodged or Dislocated (2923)

Patient Problem Asystole (4442)

Event Type  Injury  

Event Description

This ra lead was implanted on (b)(6) 2017 and was explanted on (b)(6) 2017 due to undersensing, high pacing impedance greater than 2000 ohms arid high pacing thresholds." it was also noted that upon interrogation lead exhibited loss of capture with no asystole and dislodgement.The physician was dr.(b)(6) at (b)(6) hospital - (b)(6).No other information is 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: 17531135
• MDR Text Key: 321060442
• Report Number: MW5138050
• 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: 09/20/2017

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: 346369
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1