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

Model Number	3550-43
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the needle lot# n792837 found no evidence of grind process on the undercut side spoon of the cannula.Product analysis #702725933: analysis information -- 10/31/2018 13:53:46 cst pli# 10.Product id# 3550-43 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and functional testing.Analysis determined that there was a sharp edge on the undercut side of the spoon of the needle.
Event or Problem Description
Information was received from a health care professional (hcp) via a manufacturing representative (rep) regarding a patient with an implantable neuro stimulator (ins).During the intra operative period of the trial it was reported that physician attempted to place lead through the needle and when he attempted to pull the lead through the needle to reposition the needle the lead contact became lodged at the tip of the needle so the hcp had to pull both the needle and lead out together and start over with a different needle and lead.Physician pulled the affected lead and needle out together and started over with a new needle and new lead.The issue was resolved at the time of this report.Lead never implanted.No surgical intervention occurred or planned.Patient is alive with no injury.Additional information received from a manufacturer's representative.It was reported that the cause of the lead contact becoming lodged in the tip of the needle was not determined.No further complications reported.
Additional Manufacturer Narrative
H3: analysis of the 3550-43 crvd tip (lot: n792837) revealed that the returned device passed all testing in the laboratory and no anomalies were identified.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.
Additional Manufacturer Narrative
Analysis information pli# 10 product id# 3550-43, lotno:n792837: original documentation in the analysis identified potential for grind issues on the undercut side with partial or no evidence of the grinding process.The additional analysis confirmed that there was evidence of the grinding process from the undercut side of the spoon and lab functional testing showed that using a shallow needle-insertion angle (45° or less) when inserting or withdrawing the lead into or out of the needle, no friction or catching was noted.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.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 8043346
• Report Number: 3007566237-2018-03234
• Device Sequence Number: 1498971
• Product Code: LGW
• UDI-Device Identifier: 00613994190031
• UDI-Public: 00613994190031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/19/2024

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: 03/06/2022
• Device Model Number: 3550-43
• Device Catalogue Number: 3550-43
• Device Lot Number: N792837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 05/01/2024; 08/14/2024
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 05/28/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2018
• 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...."; "SEE H11...."
• Patient Age: 58 YR
• Patient Sex: Female