MAUDE Adverse Event Report: BIOTRONIK SETROX S 53; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number S53

Device Problems Under-Sensing (1661); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2022

Event Type  malfunction  

Event Description

Atrial lead position check failed on (b)(6) 2022.Intermittent atrial undersensing observed on these episodes, leading to early termination of episodes being recorded.Atrial sensitivity programmed to 0.3mv and p wave measurements 0.3mv atrial undersensing observed on presenting rhythm.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SETROX S 53
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17524630
• MDR Text Key: 321332340
• Report Number: MW5131576
• 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: 07/05/2022

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: S53
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1