MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	SD300LG
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Application Program Problem (2880); Patient Data Problem (3197)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the device indicated as outside of the sensor sensing volume.The physician tried many different things to get it to work and never did.The physician then switched back to the old lg that did not indicate out of sensing volume but unfortunately the physician was unable to register the case due to bad scan.The physician was not able to complete the enb portion of the case and was not completed by other means.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had an open circuit.The catheter was connected to console system and extensively manually manipulated to evaluate for any signal quality and signal intermittency.Functionally, intermittency was detected.It was reported that there were issues completing registration.The reported issue was confirmed.The most likely cause could not be established from the information available.It was also reported that the locatable guide showed outside of the magnetic volume, and the patient procedure was aborted due to a system issue.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 10539291
• Report Number: 3004962788-2020-00057
• Device Sequence Number: 3123789
• Product Code: JAK
• UDI-Device Identifier: 10884521199514
• UDI-Public: 10884521199514
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: SD300LG
• Device Catalogue Number: SD300LG
• Device Lot Number: 512690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 87