MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT

Model Number	407652
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Dyspnea (1816); Tricuspid Insufficiency (2111)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 dyspnea on exertion, and further examination revealed possible poor blood flow across the tricuspid valve due to the placement of the right ventricular (rv) lead.The lead was explanted and not replaced.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.Visual summary analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSUREFIX NOVUS MRI SURESCAN
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• MDR Report Key: 7459698
• Report Number: 3008973940-2018-00810
• Device Sequence Number: 16478798
• Product Code: DTB
• UDI-Device Identifier: 00763000014643
• UDI-Public: 00763000014643
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 10/01/2019
• Device Model Number: 407652
• Device Catalogue Number: 407652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A2DR01 IPG, 407645 LEAD; A2DR01 IPG, 407645 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR