MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5086

Device Problems Pacing Intermittently (1443); Impedance Problem (2950)

Patient Problems Fall (1848); Syncope/Fainting (4411)

Event Type  Injury  

Event Description

It was reported that the patient's insertable cardiac monitor recorded four seconds of asystole, despite no episodes being stored on the implanted pacemaker.The patient underwent physical maneuvers to evaluate pacemaker system integrity and no signal noise was observed.Right ventricular (rv) lead measurements were normal, though it was noted that the rv pace impedance increased sporadically from 500-600 ohms to 1000 ohms (within normal expected limits).Technical services (ts) confirmed that the pacemaker was functioning normally, without any faults or resets.The patient experienced a second pause in pacing in which they fell down due to syncope.Ts recommended troubleshooting and programming options and it was planned to closely monitor the patient.The pacemaker and rv lead (non-boston scientific product) remain in service.Additional information is being requested, but was unavailable at the time of this report.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17534251
• MDR Text Key: 321136318
• Report Number: MW5141154
• Device Sequence Number: 1
• Product Code: NVN
• 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: 04/27/2022

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: 5086
• Device Lot Number: PJN2506761
• Patient Sequence Number: 1