MAUDE Adverse Event Report: MEDTRONIC PACEMAKER; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 5076

Device Problems Ambient Noise Problem (2877); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the patient's implantable pulse generator (pacemaker) and this right ventricular (rv) lead have a history of intermittent spikes in pacing impedance measurements with some measurements greater than 2000 ohms.Additionally, pacing inhibition of greater than two seconds was observed due to oversensing of noise.Further evaluations confirmed all lead values were stable in bipolar mode.The lead configuration was changed from unipolar pacing and bipolar sensing to bipolar mode for both as the patient was experiencing some pocket stimulation with unipolar pacing.A boston scientific boston scientific technical services consultant documented and discussed the reported clinical observations.The pacemaker and this rv lead remained in service until they were eventually explanted and surgically abandoned, respectively.Both products were replaced.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488701
• MDR Text Key: 320708497
• Report Number: MW5121400
• 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: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Patient Sequence Number: 1