MAUDE Adverse Event Report: BIOTRONIK PERMANENT PACEMAKER ELECTRODE

Model Number S53, LEAD

Device Problems Pacing Intermittently (1443); Under-Sensing (1661)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Rn stated the nursing staff report ventricular pauses a?" rn was unable to find ekg showing the pauses and unable to confirm the length at this time?" no ventricular pauses were observed on this report p-waves measure 0.3 and sensitivity is programmed 0.15mv.Potential for atrial under sensing.Appears to be atrial under sensed signal on (b)(6) 2021 stored vt egm chronic small p waves recorded by the device ll?" lead trends attached." lead manufactured by case: (b)(4) biotronik.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17529959
• MDR Text Key: 321443316
• Report Number: MW5136881
• Device Sequence Number: 1
• Product Code: DTB
• 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: 04/05/2021

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: S53, LEAD
• Patient Sequence Number: 1