MAUDE Adverse Event Report: MEDTRONIC, INC. DF-1 Y-ADAPTOR/EXTENDER KIT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	672625
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Unspecified Infection (1930)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dvbb1d1 icd, implanted (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) system was explanted due to infection of endocarditis.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.No anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DF-1 Y-ADAPTOR/EXTENDER KIT
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8923575
• Report Number: 2182208-2019-01545
• Device Sequence Number: 10823530
• Product Code: LWS
• UDI-Device Identifier: 00721902066801
• UDI-Public: 00721902066801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: Lay User/Patient
• Device Expiration Date: 08/14/2009
• Device Model Number: 672625
• Device Catalogue Number: 672625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 47 YR