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

Model Number 97715

Device Problems Break (1069); Electromagnetic Interference (1194); Delayed Charge Time (2586); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Swelling/ Edema (4577)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 13-mar-2022, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 13-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported through a manufacturer representative (rep) that they ¿suspected leads may have been cut during a recent spinal surgery.¿ impedance testing performed on (b)(6) 2021 found ¿all impedances were normal.¿ a rep involved with the event noted ¿the date on the implantable neurostimulator (ins) was out (2011), so he suspected electrocautery interference.¿ ins interrogation results from (b)(6) 2021 noted the ¿device battery had depleted to the point of therapy unavailability in the time since the last session¿ and that the ins ¿time was more than 90 minutes off from the programmer¿ used during the interrogation.The patient reported significant pain behind the ins/left buttock; an x-ray was requested.The patient reported that as of (b)(6) 2021 that they still had surgical pain from her spinal surgery and that it was consequently too difficult to tell if her spinal cord stimulation therapy was helping or not.It was noted the patient was ¿only getting additional/new pain when recharging.The ¿site also swelled and was painful during/after recharge.¿ the patient was advised to turn their charging speed down from 4 to 1 in an attempt to not heat up as much and hopefully reduce issues.The patient tried charging on 1, but noted it took too long and increased it again.The patient was advised on (b)(6) 2021 to turn her stimulation off so she didn't have to keep recharging and causing subsequent ins discomfort and swelling.The patient was reviewed by their implanting physician on (b)(6) 2021 and the hcp ¿suspected possible hematoma behind ipg from blood tracking down leads.¿ the patient was to be left to ¿settle for two weeks¿ and was advised to keep the stimulator off in order to avoid recharging until the issue settled.It was noted the rep was to ¿review her face-to-face for reprogramming and continuation of therapy if all is good by then.¿ there were no surgical interventions performed and it was unknown whether any were planned as of (b)(6) 2021.There were no further complications reported or anticipated.

Manufacturer Narrative

H6: please note that device codes a0401 and a0720 no longer apply to this report.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 received stated that x-ray imaging was performed at the (b)(6) 2021, follow-up appointment and there was ¿no issue¿ identified.It was further stated that the leads were ¿still in-situ and looked intact.¿ as such, the lead cuts suspected by the doctor were no longer suspected.It was ¿still unknown¿ whether the suspected electrocautery interference had occurred.The patient was instructed to not charge for the time being and to allow the hematoma to settle and then contact the rep when they were ready; the rep was to review with the patient after the hematoma had settled.The patient was ¿well and allowing pain at the ins site to settle¿ at the time of follow-up.No further complications were reported or anticipated.

Manufacturer Narrative

H2/g3: please note that additional information received indicates the information reported through the supplemental mdr submitted on 2021-mar-17 had an earlier notified date of 2021-feb-17, instead of the initially reported 2021-mar-07.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 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: 11387050
• MDR Text Key: 244001053
• Report Number: 3004209178-2021-03333
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2021

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: 06/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/07/2021; 04/05/2021
• Supplement Dates FDA Received: 03/17/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR