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

Model Number	511211
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of capture was reported.Syncope, fainting and loss of consciousness occurred.New lead was implanted.

• 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
• Manufacturer Contact: jacob lee ; 2300 berkshire lane; plymouth, MN 55441
• MDR Report Key: 50818467
• Report Number: 2183787-2026-00057
• Device Sequence Number: 10713052
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)250107(17)280107(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): 09/18/2026

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: 511211
• Device Lot Number: W10035716
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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