MAUDE Adverse Event Report: MEDTRONIC RV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department and was hospitalized.Upon implanted device interrogation, it was noted that the patient had inappropriately received 73 shocks and 112 bursts of anti-tachycardia pacing, (atp) for over-sensed right ventricular (rv) lead noise.Additionally, there was evidence of over-sensed atrial arrhythmia noise on the ventricular channel.Provocative maneuvers were performed which easily reproduced the noisy signals.Therapy was subsequently programmed off and technical services (ts) were contacted for data review and recommendations.Ts confirmed the presence of over-sensed mechanical and atrial arrhythmia noise from the rv lead, as well as minute-ventilation (mv) feature signal over-sensing.Furthermore, the rv lead trends showed jumpy threshold and amplitude measurements.It was discussed that the over-sensing of the atrial arrhythmias could be the result of the rv lead coil close to the valve, due to potential lead movement or indicative of potential rv insulation damage.Thorough testing recommendations and diagnostic imaging were discussed.A few days later, ts was contacted again and it was stated the physician had elected to surgically downgrade the patient to a pacemaker system.The previous implantable device was explanted.The rv lead and non-boston scientific right atrial (ra) lead were surgically capped and abandoned.The patient was stable with no additional adverse patient effects.The device is not expected to be returned for analysis and the rv lead remains implanted, but capped and out-of-service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17536234
• MDR Text Key: 321138836
• Report Number: MW5143124
• 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: 07/19/2022

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: 5076
• Device Lot Number: PJN2315687
• Patient Sequence Number: 1