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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Energy Output Problem (1431); Application Program Problem (2880); Impedance Problem (2950); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2021

Event Type  Injury  

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that a sudden increase in stimulation was felt on (b)(6) 2021 after which, a feeling of stimulation disappeared.The patient controller was checked and ¿it was displayed that the set value could not be used.¿ the patient visited the hospital on (b)(6) 2021 and an impedance test was performed.It was found that electrode #12 had a high impedance.The patient¿s stimulus was adjusted and they were changed to a program that used electrode #13 in an effort to troubleshoot the issue; however, ¿it was displayed again that the set value could not be used.¿ the patient later visited the hospital on (b)(6) 2021, at which time impedance testing was performed and found the ¿results differed depending on the posture.¿ it was stated that while impedances measured with the patient in the supine position were normal, electrodes 9, 12, and 13 were found to have high resistance when the patient was in a sitting position.The patient was reprogrammed with electrodes that provided coverage and pain relief.It was noted that an ¿electrode connection failure or fracture was suspected¿ and that this may have led or contributed to the issue.It was further noted that there were no plans for reoperation as of (b)(6) 2021 and that if the number of electrodes that could not be used increased in the future and the therapeutic effect became insufficient, reoperation would be considered.Additional information received from an hcp through a manufacturer representative reported that after high impedances were first observed on (b)(6) 2021 that ¿at first, two electrodes were abnormal, but after that, the number unusable electrodes increased and as of (b)(6) 2021, the impedance anomaly of seven electrodes occurred.¿ it was noted that at first lead replacement was considered; however, ¿due to the decrease in reliability of the system, the whole system was removed at the patient¿s request¿ on (b)(6) 2021.It was unknown whether any external factors may have led or contributed to the issue.After the abnormal impedance value first occurred, the patient¿s stimulation was adjusted in order to avoid the unusable electrodes and the effect was temporarily restored; however, the patient¿s treatment was stopped and the whole system was ultimately removed as of (b)(6) 2021.The issue was considered resolved at that time.There were no further complications reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 977a275 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2021 product type lead product id 977a275 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2021 product type lead product id 97791 lot# serial# unknown : product type accessory product id 97791 lot# serial# unknown product type accessory h2.Correction: please note, codes b17 and c20 no longer apply to this report.H3.The returned lead (serial # (b)(6)) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that all conductors were broken; 18.5 cm from the distal end of the lead.The returned ins (serial # (b)(6)) was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.H6.Please note, codes c070603 and d215 apply to the lead, and codes c19 and d14 apply to the ins.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: INTELLIS
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12928646
• MDR Text Key: 286007174
• Report Number: 3004209178-2021-17965
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Male