MAUDE Adverse Event Report: GREATBATCH MEDICAL MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD; BIPOLAR EPICARDIAL LEAD

Model Number	511211
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
High capture threshold was reported.Implanted device from different manufacturer was replaced due to the issue and the greatbatch lead remains in service.

• Brand Name: MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD
• Common Device Name: BIPOLAR EPICARDIAL LEAD
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• Manufacturer (Section G): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• Manufacturer Contact: jacob lee ; 2300 berkshire lane; plymouth, MN 55441
• MDR Report Key: 24916389
• Report Number: 2183787-2026-00024
• Device Sequence Number: 9067184
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)190301(17)220301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 511211
• Device Lot Number: W4798638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2019
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male