MAUDE Adverse Event Report: MEDTRONIC, INC. LEAD ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER

Model Number	5866-38M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation (2443)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddmc3d1 icd, implanted: (b)(6) 2018; 6721s-50, lead, implanted: (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient complained of having a skin boil above where the implantable cardioverter defibrillator was implanted.The patient was initially treated with intravenous antibiotics.The icd system was then removed due to infection.The patient was provided with lifevest before being discharged home.No further patient complications have been reported as a result of this event.

• Brand Name: LEAD ADAPTOR KIT
• Common Device Name: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10782040
• Report Number: 2182208-2020-02641
• Device Sequence Number: 3486200
• Product Code: DTD
• UDI-Device Identifier: 00681490136907
• UDI-Public: 00681490136907
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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: 01/28/2013
• Device Model Number: 5866-38M
• Device Catalogue Number: 5866-38M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/03/2020
• 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: 30 YR
• Patient Weight: 92