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

Model Number	407458
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Swelling (2091)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 500fa23 mechanical valve, implanted: (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced a pocket infection with swelling, white drainage and fever.The implantable pulse generator (ipg) system was explanted and a temporary lead was implanted with the explanted ipg used externally.The patient was treated with antibiotics and a new system will be implanted in the future.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE SENSE LEAD 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: 8883702
• Report Number: 3008973940-2019-02237
• Device Sequence Number: 16666285
• Product Code: DTB
• UDI-Device Identifier: 00643169448957
• UDI-Public: 00643169448957
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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: 11/08/2019
• Device Model Number: 407458
• Device Catalogue Number: 407458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/12/2019
• 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: W1DR01 IPG, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 68