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

Model Number	407645
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762)
Date of Event	01/25/2022
Type of Reportable Event	Death
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 is deceased.It was further reported the patient experienced bradycardia and cardiac arrest.It was further reported that intermittent ventricular capture of the right ventricular (rv) lead was noted on presenting electrograms (egm) and the right atrial (ra) lead exhibited far field r-wave (ffrw) oversensing.It was further reported that the patient went into cardiac arrest prior to reprogramming.
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 is deceased.It was further reported the patient experienced bradycardia and cardiac arrest.It was further reported that intermittent ventricular capture of the right ventricular (rv) lead was noted on presenting electrograms (egm) and the right atrial (ra) lead exhibited far field r-wave (ffrw) oversensing.It was further reported that the patient went into cardiac arrest prior to reprogramming.

• Brand Name: CAPSUREFIX NOVUS MRI SURESCAN
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13567003
• Report Number: 3008973940-2022-00777
• Device Sequence Number: 20288439
• Product Code: DTB
• UDI-Device Identifier: 00763000014636
• UDI-Public: 00763000014636
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 11/06/2019
• Device Model Number: 407645
• Device Catalogue Number: 407645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Date Device Manufactured: 11/22/2017
• 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: 407652 LEAD,A2DR01 IPG.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 69 KG