MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSURE SENSE LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

Model Number	407458
Medical Device Problem Code	Decreased Sensitivity (2534)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2022
Type of Reportable Event	Malfunction
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 right ventricular (rv) lead exhibited chronically low r waves and that the right atrial (ra) lead exhibited intermittent undersensing.Both pacing leads remain in use. no further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE SENSE LEAD 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: 14842231
• Report Number: 3008973940-2022-02729
• Device Sequence Number: 14048495
• Product Code: DTB
• UDI-Device Identifier: 00643169448957
• UDI-Public: 00643169448957
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/03/2019
• Device Model Number: 407458
• Device Catalogue Number: 407458
• 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: 06/04/2022
• Initial Report FDA Received Date: 06/28/2022
• Date Device Manufactured: 11/01/2017
• 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: 5076-52 LEAD, W1DR01 IPG
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 16 KG