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

Model Number	977C165
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: product id: 97725, serial#: (b)(4), product type: external neurostimulator.Product id: 97715, serial#: (b)(4), implanted: (b)(6) 2022, product type: implantable neurostimulator.Product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2022, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a trial patient who was using an external neurostimulator (ens) for unknown indications for use.It was reported that contacts 2 and 4 showed a bad connection no matter which channel it was plugged into in the wens and the ins.It was unknown if there were any contributing factors.The surgeon wiped the leads off with a damp ray tech and a dry one, changed the lead tails between the two channels in the wens and the ins and the bad connection followed the lead tail on the first lead.That lead was then swapped out and a new lead was used.This lead had the same bad connections on the same lead tail regardless of the channel in both the wens and ins.The surgeon continued to wipe and readjust and eventually contact 4 improved, but contact 2 remained with a bad connection.In the end this lead showed contacts 2 and 4 were normal, but contact 6 showed red (40 ,000).
Additional Manufacturer Narrative
Concomitant product id 97725 lot# serial# (b)(6) product type external neurostimulator product id 97715 lot# serial# (b)(6) implanted: (b)(6) 2022 product type implantable neurostimulator product id 977c165 lot# serial#(b)(6) implanted: (b)(6) 2022 product type lead 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.
Event or Problem Description
Additional information was received from the manufacturer representative (rep) reporting that the remaining high impedances on contact 6 did not resolve in post-op.The rep however did indicate that they were able to program around the high impedances to obtain effective therapy for the patient.The rep indicated that the lead that was swapped out was not returned yet but would be placed in the mail on 1/12/2022.The mail tracking number was provided.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.
Additional Manufacturer Narrative
H3: product analysis pli# 10 product id# 977c165 the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.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: SPECIFY 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: 13185481
• Report Number: 2649622-2022-00367
• Device Sequence Number: 16688114
• Product Code: LGW
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/30/2022

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: Health Professional
• Device Expiration Date: 03/26/2025
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 01/11/2022; 03/09/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/19/2022; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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...."
• Patient Age: 65 YR
• Patient Sex: Male