MAUDE Adverse Event Report: MEDTRONIC, INC. UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6721L-50
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) epicardial patch, left ventricular (lv) epicardial patch, and rv lead were abandoned due to a potential product performance issue.A new rv lead was implanted. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 4968-60 lead implanted: (b)(6) 2005 ddbb1d1 icd implanted: (b)(6) 2019 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18998697
• Report Number: 2182208-2024-01374
• Device Sequence Number: 11480008
• Product Code: LWS
• UDI-Device Identifier: 00681490148733
• UDI-Public: 00681490148733
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/28/2006
• Device Model Number: 6721L-50
• Device Catalogue Number: 6721L-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4968-60 LEAD, 6721L-50 PATCH, 305C27 VALVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male