MAUDE Adverse Event Report: GREATBATCH PLYMOUTH LD MY SUTLES BP 4046 35CM; Implantable Lead

Model Number	4046
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and this left ventricular (lv) lead exhibited a low out of range pacing impedance measurement, less than 200 ohms.Technical services (ts) noted there was no noise recorded and the device was capturing.Ts recommended to continue to monitor.This lv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: LD MY SUTLES BP 4046 35CM
• Common Device Name: Implantable Lead
• Manufacturer (Section D): GREATBATCH PLYMOUTH; 2300 berkshire ln n; minneapolis MN 55441
• Manufacturer (Section G): GREATBATCH PLYMOUTH; 2300 berkshire ln n; minneapolis MN 55441
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25786366
• Report Number: 2124215-2026-37135
• Device Sequence Number: 13433731
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)250601(17)280601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 4046
• Device Catalogue Number: 4046
• Device Lot Number: 355865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 07/13/2026; Not provided
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 07/13/2026; 08/24/2026
• Date Device Manufactured: 06/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male