MAUDE Adverse Event Report: MEDTRONIC, INC. SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6996SQ58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-45 lead, implanted: (b)(6) 2009; 4968-35 lead, implanted: (b)(6) 2014; t510c29 tissue valve, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced an infection.The original source of the infection was noted to be in the device pocket.The cardiac resynchronization therapy defibrillator (crt-d) device, right atrial (ra) and right ventricular (rv) his bundle leads were explanted.The right ventricular (rv) and epicardial leads were partially explanted.A new implantable pulse generator (ipg) system was implanted.No further patient complications have been reported as a result of this event.

• Brand Name: SUBCUTANEOUS, UNIPOLAR LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9565973
• Report Number: 2182208-2020-00046
• Device Sequence Number: 2224661
• Product Code: LWS
• UDI-Device Identifier: 00721902183072
• UDI-Public: 00721902183072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 08/28/2015
• Device Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/08/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 71