MAUDE Adverse Event Report: GREATBATCH PLYMOUTH LD MY SUTLES BP 4046 35CM; IMPLANTABLE CARDIAC LEAD

Model Number	4046
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Pacing Problem (1439)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Asystole (4442)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker and left ventricular (lv) lead exhibited noise and loss of capture resulting in pacing inhibition and syncope.The patient was subsequently hospitalized.The lv lead was surgically abandoned and the device was explanted.A new transvenous system was implanted as a replacement.This lead remains implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker and left ventricular (lv) lead exhibited noise and loss of capture resulting in pacing inhibition and syncope.The patient was subsequently hospitalized.The lv lead was surgically abandoned and the device was explanted.A new transvenous system was implanted as a replacement.This lead remains implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes our investigation of this event is complete.This report will be updated should additional information be provided.Device history record (dhr) review: a review of the dhr was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: the complaint device was not returned to boston scientific, therefore product analysis could not be performed.The primary reported observation is addressed in product labeling (e.G.Instructions for use).Therefore, well-understood factors likely contributed to the event.Investigation conclusion: in the absence of physical analysis, the root cause of the reported noise, loss of capture and pacing inhibition cannot be determined.

• Brand Name: LD MY SUTLES BP 4046 35CM
• Common Device Name: IMPLANTABLE CARDIAC 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 ; 6515826168
• MDR Report Key: 24282596
• Report Number: 2124215-2026-06959
• Device Sequence Number: 9862650
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)230801(17)260801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/01/2026
• Device Model Number: 4046
• Device Catalogue Number: 4046
• Device Lot Number: 339910
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 08/01/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown