MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977A260
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 2021-nov-04, information was received from a manufacturer representative regarding a trial patient who was using an external neur ostimulator (ens).It was reported that caller is in or and tested leads with wens.It was not known at the time of the call if this was a replacement case.When they switched to the ins the lead contacts were showing avoid/>40000 on contacts 0 1 4 5 8 9 10.Caller reported they removed and dried and still found high impedances.Caller reported they swapped the tails and the impedance issue followed in pattern.Caller changed reference electrodes and noted they previously mentioned contacts were showing >40000.Reviewed programming around or replacing the leads.Did not ask additional questions as caller had to go get leads.Rep said he used new tablet and it didn't work, still had impedance issue.Rep tried new wens but still the same result.Hcp tried 2 new leads and they still showed high impedances, but hcp decided to leave them and hope the impedance will eventually resolve.Rep to send back equipment for analysis.On 2022-01-27, additional information was received from the manufacturer representative (rep) clarifying that the patient was having surgery for implantation of an upgraded ins model and leads.It was indicated that the impedance issue on the new system left implanted in the patient had resolved.The patient¿s medical doctor did not have the patient¿s new system turned on until the patient¿s post op appointment.The rep did not need to program around any impedance issues at that time as the impedances had resolved.The patient was programmed with dtm.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.See related regulatory report # 2649622-2024-03813 2021-nov-11 rp (rep): no new information.2021-11-22 no new information 2022-01-27 e1 (rep): additional information was received from the manufacturer representative (rep) clarifying that the patient was having surgery for implantation of an upgraded ins model and leads.It was indicated that the impedance issue on the new system left implanted in the patient had resolved.The patient¿s medical doctor did not have the patient¿s new system turned on until the patient¿s post op appointment.The rep did not need to program around any impedance issues at that time as the impedances had resolved.The patient was programmed with dtm.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.
Additional Manufacturer Narrative
H3.Analysis of the lead va2fzby010 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
G4.Correction: 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: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18681971
• Report Number: 3007566237-2024-00003
• Device Sequence Number: 12310753
• Product Code: LGW
• UDI-Device Identifier: 00763000006501
• UDI-Public: 00763000006501
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 08/04/2025
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Device Lot Number: VA2FZBY010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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 Sex: Unknown