MAUDE Adverse Event Report: GREATBATCH MEDICAL LEAD ADAPTOR; 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	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported the lead adapter was explanted due to infection.

• Brand Name: LEAD ADAPTOR
• Common Device Name: BIPOLAR EPICARDIAL LEAD ADAPTER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• Manufacturer Contact: rhonda stager ; 2300 berkshire lane; plymouth, MN 55441 ; 7639518376
• MDR Report Key: 13591185
• Report Number: 2183787-2022-00007
• Device Sequence Number: 12240475
• Product Code: DTD
• UDI-Device Identifier: 00821329900280
• UDI-Public: (01)00821329900280(11)20170901(17)200901
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K870562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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: 09/01/2020
• Device Model Number: 501214
• Device Lot Number: W4113507
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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