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); High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient revised an lv epicardial lead that had >3000 ohm impedance and no capture in any vector.Patient notifier was delivered in 6-5-25 for lead impedance out of range (<200).Today the pocket was opened, the lv lead disconnected from the generator and tested.160 ohms lvr-rvc, >3000 ohms in other vectors and no lv capture in any vector.The lead was capped.

• 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: 23294282
• Report Number: 2183787-2025-00050
• Device Sequence Number: 21313777
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)181201(17)211201
• 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: 2024
• 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): 10/14/2025

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: W8858520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 77 KG