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

Model Number	511212
Medical Device Problem Codes	Failure to Sense (1559); Low impedance (2285)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient implanted with rv lead suffered from twiddler's syndrome.The physician opted to perform a device revision procedure to suture the device down in the pocket to prevent twiddling.Lead measurements were noted to be within normal limits prior to opening the device pocket.The pocket was then opened and the device was sutured to the pectoral muscle.The pocket was then closed and the lead was retested.The rv lead was no longer sensing in bipolar configuration and pacing impedance measurements were less than 200 ohms.Threshold measurements were noted to be stable, so sensing was reprogrammed to unipolar.It was noted that the device was programmed to left ventricular (lv) only pacing.This device 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: 24635112
• Report Number: 2183787-2026-00017
• Device Sequence Number: 8985581
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)240701(17)270701(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: 2025
• 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): 03/18/2026

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: 511212
• Device Lot Number: W9308911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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