MAUDE Adverse Event Report: GREATBATCH MEDICAL MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54CM; BIPOLAR EPICARDIAL LEAD

Model Number 511212

Device Problems Failure to Capture (1081); Fracture (1260); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

There was no sensing and no capture at 10v.Under fluoro, a conductor fracture was observed.A cs lead was then placed, and the epi lead was capped.

• Brand Name: MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54CM
• Type of Device: 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: 18954518
• MDR Text Key: 338355188
• Report Number: 2183787-2024-00020
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)231201(17)261201(20)00
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 511212
• Device Lot Number: W8794064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female