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

Model Number 511212

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

Epicardial lead placement because of lead issue was reported.Lead remained implanted and inactive.

• 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; minneapolis, MN 55441
• MDR Report Key: 18907244
• MDR Text Key: 337737676
• Report Number: 2183787-2024-00019
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)160801(17)190801
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 511212
• Device Lot Number: W3588115
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• 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 Age: 65 YR
• Patient Sex: Male