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

Model Number	501206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported lead adapter was explanted due to infection.This is a similar event mdrs 2183787-2021-00109 & 2183787-2021-00110.
Additional Manufacturer Narrative
Disinfectant (i.E.Cidex opa) in accordance with its manufacturer's recommendations and therefore, most if not all microorganisms were eliminated from the device.Since infection results from the presence of microorganisms, additional testing to attempt to identify the source of infection is not feasible.

• Brand Name: LEAD ADAPTOR
• 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: daniel gil de lamadrid ; 2300 berkshire lane; plymouth, MN 55441
• MDR Report Key: 13078010
• Report Number: 2183787-2021-00111
• Device Sequence Number: 12218396
• Product Code: DTD
• UDI-Device Identifier: 00821329900266
• UDI-Public: (01)00821329900266(11)190201(17)220201
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 02/01/2022
• Device Model Number: 501206
• Device Lot Number: W4759503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2019
• 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