MAUDE Adverse Event Report: GREATBATCH MEDICAL LEAD ADAPTER; BIPOLAR EPICARDIAL LEAD ADAPTER

Model Number	501214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Lead adapter was explanted due to infection.

• Brand Name: LEAD ADAPTER
• Common Device Name: BIPOLAR EPICARDIAL LEAD ADAPTER
• 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: 21451797
• Report Number: 2183787-2025-00008
• Device Sequence Number: 7761143
• Product Code: DTD
• UDI-Device Identifier: 00821329900280
• UDI-Public: (01)00821329900280(11)211101(17)241101
• 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: 2024
• Device Explanted 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): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: 501214
• Device Lot Number: W6881856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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