MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problems Disconnection (1171); Energy Output Problem (1431); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Insufficient Information (4580)

Event Date 08/07/2020

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 via manufacturer representative.It was reported that patient has stim lead placed at t3.Impedences and lead connectivity showed 0-7 not connected in implantable neurostimulator (ins).Patient noticed change in coverage a month ago.Patient does not remember any fall or major twisting, however, landscaper as occupation.Actions/interventions that were taken to resolve the issue were x-ray and consult for lead revision, that will be scheduled.The issue was not resolved at the time of the report.Additional information was received from the manufacturer representative (rep).Manufacturer representative (rep) reported that the revision surgery had not been scheduled.The lead serial number could not be verified.

Manufacturer Narrative

Continuation of d10: product id: 977a275, lot#/serial# (b)(6), explanted: (b)(6) 2020, product type: lead.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 Description

Additional information was received from the manufacturer representative (rep) and it was reported that the patient had 0-7 connectivity issues and impedances on 1, 4, 6 contacts.Tried to reconnect 0-7 while in surgery and no improvement.Effected lead was removed and replaced.Replacement of lead was successful and there is no further information available.The issue was resolved.The lead was discarded.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10423215
• MDR Text Key: 203494106
• Report Number: 3004209178-2020-14301
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR