MAUDE Adverse Event Report: Greatbatch Medical Myopore® Sutureless Myocardial Pacing Lead; Bipolar Epicardial Lead

Model Number	511212
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); Device Sensing Problem (2917); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure of epicardial left ventricular lead was reported.Required urgent implant of new leadless pacemaker.Conductor fracture, impedance change with significant sensing and capture issues were reported.

• 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: 50378511
• Report Number: 2183787-2026-00055
• Device Sequence Number: 5639205
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)240901(17)270901(20)00
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/21/2026

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 Model Number: 511212
• Device Lot Number: W9437760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown