MAUDE Adverse Event Report: Greatbatch Plymouth LD MY SUTLES BP 4046 35CM; Implantable lead

Model Number	4046
Medical Device Problem Codes	Low impedance (2285); Device Sensing Problem (2917); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the physician attempted to use this left ventricular (lv) lead.While attempting to use the lead, the sensing was not performing appropriately, the pacing impedances were low out of range, and the lead appeared to be fractured.It was noted when the lead was squeezed together, the sensing was working.The physician opted to complete the procedure with a new lead.No additional adverse patient effects were reported.This lv lead has not been returned for analysis.
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: 50196758
• Report Number: 2124215-2026-42639
• Device Sequence Number: 10274774
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)240801(17)270801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 350563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 08/01/2024
• 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: 62 YR
• Patient Sex: Female