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

Model Number	501214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thee leads and adapter were explanted due to infection/erosion.This is similar to events mdr 2183787-2019-00091, mdr 2183787-2019-00092, & mdr 2183787-2019-00093.

• Brand Name: LEAD ADAPTOR
• Common Device Name: BIPOLAR EPICARDIAL LEAD
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• MDR Report Key: 9243734
• Report Number: 2183787-2019-00094
• Device Sequence Number: 14436771
• Product Code: DTD
• UDI-Device Identifier: 00821329900280
• UDI-Public: 00821329900280
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention