MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; REPLACEMENT HEART-VALVE

Model Number	HC105-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the device remains implanted; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure and can be resolved with medical treatment or the implant of a permanent pacemaker.A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 6 days post implant of this 20mm pulmonary valved conduit in a (b)(6) pediatric patient, a permanent pacemaker was implanted.The reason for the permanent pacemaker was reported as sick sinus syndrome.No additional adverse patient effects were reported.

• Brand Name: HANCOCK
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12173381
• Report Number: 2025587-2021-02198
• Device Sequence Number: 10990251
• Product Code: DYE
• UDI-Device Identifier: 00643169646520
• UDI-Public: 00643169646520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P870078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: Health Professional
• Device Expiration Date: 12/18/2024
• Device Model Number: HC105-20
• Device Catalogue Number: HC105-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/15/2021
• 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: 10 YR