MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS VERSA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	VEDR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: esbf3214c103e stent graft, implanted (b)(6) 2019; etlw1616c156e stent graft, implanted (b)(6) 2019; etlw1620c124e stent graft, implanted (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient died.Follow-up was attempted to obtain the relevant information; however, no additional details are available at this time.This event is being conservatively reported in an abundance of caution in response to the advisory describing the potential for device circuit error to occur while the device is processing an atrial-sensed episode.

• Brand Name: VERSA IPG
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 12973017
• Report Number: 3008973940-2021-04604
• Device Sequence Number: 19902907
• Product Code: NVZ
• UDI-Device Identifier: 00643169709072
• UDI-Public: 00643169709072
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: Lay User/Patient
• Device Expiration Date: 03/28/2019
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/09/2021
• Date Device Manufactured: 10/08/2017
• 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: 5076-58 LEAD, 457453 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male