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

Model Number NEU_INS_STIMULATOR

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product(s): product id: 3877-45, lot# b0890410k, implanted: (b)(6) 2009, explanted: (b)(6) 2019, product type: lead.Product id: 37081-20, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: extension.Product id: 7472-20, serial# unknown, product type: extension.Other relevant device(s) are: product id: 3877-45, serial/lot #: (b)(4), ubd: 10-dec-2012, udi#: (b)(4); product id: 37081-20, serial/lot #: (b)(4), ubd: 24-mar-2021, udi#: (b)(4); product id: 7472-20, serial/lot #: unknown, ubd: 24-mar-2021.If information is provided in the future, a supplemental report will be issued.

Event Description

2019-11-25 mpxr 681297, email, rp (for, rep, hcp): the healthcare provider reported via manufacture representative that the extension could not connect to the lead.No further complications were reported or anticipated.

Manufacturer Narrative

H3.Device analysis for lead (b)(6) revealed proximal end insulation consistent with metal ion oxidation (environmentally assisted degradation of the insulation).Device analysis for extension (b)(6) revealed no anomalies.Device analysis for extension unknown revealed no significant anomaly.The body was cut thru, product segmented.H6 codes belong to the lead and extensions.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: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9510336
• MDR Text Key: 182603071
• Report Number: 3007566237-2019-02602
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention