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

Model Number 693558

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 health care provider (hcp) reached out to technical services (ts) for review and consultation of the patient's presenting electrogram (egm).Upon review, it was determined that there were noisy signals and oversensing on this non-boston scientific right atrial lead.Isometric testing was performed and noisy signals on the non-boston right ventricular lead were also observed.Lead impedances were reportedly within range during the episode.Additionally, the patient with the implantable cardioverter defibrillator (icd) heard beep tones.Ts explained the possible causes of the tones and indicated that the beeping does not appear to be coming from the device.The icd was an elective replacement indicator (eri).Troubleshooting options were discussed.At this time, the icd system remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RA LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17530654
• MDR Text Key: 321376266
• Report Number: MW5137572
• 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: 08/24/2022

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: 693558
• Device Lot Number: TAU136461V
• Patient Sequence Number: 1