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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); No Code Available (3191); Constipation (3274)

Event Date 09/01/2007

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient.It was reported that their first implantable neurostimulator (ins) was to address pain at the bottom of their feet, so the leads were implanted at the s1 nerve root in their sacrum.The patient reported that the incision at the lead site got infected and their physician opted to keep the hardware in for six months and was trying to treat it with antibiotics.After six months, this had developed into a staph infection so the physician performed a full system explant and waited to years before having another ins implanted.The patient stated that because of the infection they now have terrible pelvic pain.It was noted that the issue occurred in (b)(6) 2007.No further complications were reported or anticipated.Indication for use is non-malignant pain.

Event Description

Additional information was received from the patient.It was reported that the patient still lives with pelvic pain, which lead to rectal weakness.It was reported that the neurosurgeon figured out a way to get the leads for the patient's feet placed in their sciatic nerve.The patient reported that they started having lower groin pain.The groin pain led to pelvic floor pain, which was determined to have been caused by scar tissue that had resulted from the infection trapping a nerve in the rectum.The patient reported that they could not expel or have bowel movements in 2012, so they had a colostomy.The patient had to have their rectum removed in 2013 due to mucous build up.No further complications are anticipated.

Manufacturer Narrative

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: 9181187
• MDR Text Key: 170045091
• Report Number: 3007566237-2019-02112
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR