MAUDE Adverse Event Report: GREATBATCH PLYMOUTH; IMPLANTABLE LEAD

Model Number	4047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted and successfully due to an anomaly unrelated to the performance of the lead.No additional 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.
Additional Manufacturer Narrative
Initial mdr report number 2124215-2026-22243 was sent in error.This model is not bsc reporting responsibility.
Event or Problem Description
It was reported that this left ventricular (lv) lead was surgically abandoned and successfully replaced due to an anomaly unrelated to the performance of the lead.No additional adverse patient effects were reported.

• 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 ; 6515826168
• MDR Report Key: 24974816
• Report Number: 2124215-2026-22243
• Device Sequence Number: 4954865
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)190201(17)220201
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K925099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 02/01/2022
• Device Model Number: 4047
• Device Catalogue Number: 4047
• Device Lot Number: 289627
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 06/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/27/2026; 07/01/2026
• Date Device Manufactured: 02/01/2019
• 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 Age: 79 YR
• Patient Sex: Male