MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT 355028 ACCESSORY-NEEDLE,TOUHY,14GA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	355028
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 355028 (hg4uvfa); product type: 0001-accessory; implant date n/a; explant date n/a b3: event date is date valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins).Rep reported they were given product by an employee for a case the same day.Leading up to the case, rep did not look at the expiration date on the product they were given.The product was only needed if the current needle in the lead kit was too short for access.When the doctor asked rep for the 6 inch needles, rep then noticed that they expired in november 2024.Rep made the physician and staff aware of the expired product.Rep gave them the option of a curved 6 inch access needle which they declined.The physician insisted on still using the expired access needles.Therefore, they used 2 expired (b)(6) during the procedure.Rep noted the issue was resolved and the needles were discarded.
Event or Problem Description
Additional information was received, it was reported the needle in the kit was not long enough for the procedure.The manufacturer representative (rep) gave the physician an alternative to use curved needles, however they refused.The physician used the expires 6 inch needle.The issue was resolved.
Additional Manufacturer Narrative
Continuation of d10: product id 355028 lot# hg4uvfa: product type accessory medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: KIT 355028 ACCESSORY-NEEDLE,TOUHY,14GA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21421603
• Report Number: 3004209178-2025-03237
• Device Sequence Number: 18121120
• Product Code: LGW
• UDI-Device Identifier: 00643169986411
• UDI-Public: 00643169986411
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/21/2025

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: 11/13/2024
• Device Model Number: 355028
• Device Catalogue Number: 355028
• Device Lot Number: HG4UVFA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 11/13/2020
• 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 H11....".; SEE H11...
• Patient Age: 74 YR
• Patient Sex: Female