MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977D260
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 2021-may-03, information was received from a manufacturer representative (rep) regarding a patient who was implanted with an impl antable neurostimulator (ins) for unknown indications for use.It was reported that the trial lead was opened and the physician attempted to place the lead.However, the lead looked to be a little distorted or bent.The doctor removed the stylet to see if the stylet was bent but it was not.He placed the stylet back into the lead and again the lead looked distorted.There seemed to be some slight resistance in inserting the lead but there was no ¿forcing¿ of the lead or aggressive torking of the lead.The physician requested a new lead.There were no issues with the new lead.The issue was resolved at the time of the report.On 2021-may-14, additional information was received from the rep and it was reported that the cause of the issue with the lead was not determined.The lead was sent for analysis.On 2021-05-13, additional information received.Rep reported lead was wavy, unable to guide lead into place.Difficulty steering.Recovered without sequalae.
Additional Manufacturer Narrative
Continuation of d10: product id neu_stylet_acc lot# unknown product type accessory h3.Analysis of the lead (b)(6) found no anomalies.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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.
Additional Manufacturer Narrative
Continuation of d10: product id neu_stylet_acc lot# unknown serial# implanted: explanted: product type accessory correction: g4 missing in initial report 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: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18607118
• Report Number: 2649622-2024-02798
• Device Sequence Number: 21114264
• Product Code: LGW
• UDI-Device Identifier: 00763000006570
• UDI-Public: 00763000006570
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: Health Professional
• Device Expiration Date: 03/12/2025
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/19/2024
• Date Device Manufactured: 03/12/2021
• 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: "SEE H10...."; "SEE H11...."
• Patient Age: 56 YR
• Patient Sex: Female