MAUDE Adverse Event Report: MEDTRONIC, INC. IS-1 BI LEAD TO IS-1 BI IPG - PERMANENT LEAD EXTENSION KIT; ADAPTOR, LEAD, PACEMAKER

Model Number	6984M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6984m accessory, implanted: (b)(6) 2017; 672637 accessory, implanted: (b)(6) 2017; dtba1d1 device, implanted: (b)(6) 2016; 6984m accessory, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was extracted due to infection.No further patient complications have been reported as a result of this event.

• Brand Name: IS-1 BI LEAD TO IS-1 BI IPG - PERMANENT LEAD EXTENSION KIT
• Common Device Name: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7566584
• Report Number: 2182208-2018-01028
• Device Sequence Number: 1758601
• Product Code: DTD
• UDI-Device Identifier: 00681490153621
• UDI-Public: 00681490153621
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K915724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: Lay User/Patient
• Device Expiration Date: 09/18/2017
• Device Model Number: 6984M
• Device Catalogue Number: 6984M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935-65 LEAD, 4076-45 LEAD, 4194-78 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR