MAUDE Adverse Event Report: NEURO - VILLALBA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	3778-60
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 3778-60 lot# serial# (b)(6) implanted: (b)(6) 2013, product type lead product id 97715 serial# (b)(6) implanted: (b)(6) 2023, product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(6), ubd: 30-jan-2017, udi#: (b)(4) ; product id: 97715, serial/lot #: (b)(6), ubd: 28-mar-2024, udi#: (b)(4) 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
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that there were high impedances greater than 40,000 ohms on contacts 10, 11, and 14.23,000 and 16,910 on contacts 9 and 13.Impedances were checked during an ins replacement case as a result of normal end of service (eos).Previous 97714 was completely depleted at the time of pre-op and the procedure.It is possible that this lead has had impedance issues since before the case today. impedance check was completed after implanting new ins and checking connections.The cause was unknown.Issue remains ongoing.Additional information from the rep indicated that dtme was programmed at surgery.They noted that the patient has not been seen for post-op reprogramming yet.
Event or Problem Description
Additional information was received from the rep.It was reported that they have been able to work around the contacts.
Additional Manufacturer Narrative
Continuation of d10: product id 3778-60 lot# serial# (b)(6) implanted: (b)(6) 2013 product type lead product id 97715 serial# (b)(6) implanted: (b)(6) 2023 product type implantable neurostimulator 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: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17136810
• Report Number: 6000153-2023-00008
• Device Sequence Number: 3929373
• Product Code: LGW
• UDI-Device Identifier: 00643169157330
• UDI-Public: 00643169157330
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 07/11/2023

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: 01/17/2017
• Device Model Number: 3778-60
• Device Catalogue Number: 3778-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/11/2023
• Date Device Manufactured: 01/17/2013
• 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: 67 YR
• Patient Sex: Female