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); Failure to Interrogate (1332); Unstable (1667); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that they've been having issues while charging their implant the last couple weeks and issues are worsening.Pt reported reposition recharger continues to display while attempting to charge and now they're unable to charge at all.Pt stated their implant is depleted at this point and they depend on their therapy.Pt also stated system problem rm04 displayed.An email was sent to the repair department to replace the recharger.[see crts/case # (b)(4) for the report of pt mentioned they had issues while charging their implant in the past.]' additional information was received and it was reported they weren't able to charge the implant.They tried all night and weren't able to charge.Patient described the passive recharge screen.Patient stated she never see the passive recharge screen before.Ps reviewed function of device and passive recharge process.Patient (pt) called back on stating that they were never able to proceed past passive recharge mode, pt attempted to charge for hours last night and they could not charge their implant.Pts controller was fully charged and the implant had been with out stimulation for 2 days and they were starting to get in pain.During call pt attempted to charge implant, they proceeded through passive recharge mode.Pt was unable to charge their implant for they kept on receiving the message unable to recharge ensure the recharger is over your implanted device.Additional information received.Caller is with pt today because pt received product sent from the related case but the pt is only getting passive recharge screen--caller notified of only getting passive charge screen today.Tss attempted to resolve this issue by having the caller pair the pt ctrl with the ins (it was not paired to start) and then do a 'disable device' but the caller was unable to pair the device today and thus unable to disable.The caller states ins is tilted.The caller tried to use their fa 97745 with the pt's li battery but they could not pair, the controller kept saying to reposition.The caller tried different positions and tried having the pt in different positions but the device would not pair.The paring issue is occurring today.Tss to send case number to caller if she needs to call back, the caller will continue to try to pair the controller.*tss is including the passive charge issue with the unable to pair (which is event/notify today) as they are related and occurring together today and not allowing pt to continue therapy.See related cases for more info.Caller is with the pt today to address issues in related cases.

Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(6)implanted: explanted: product type recharger product id 97745 lot# serial#(b)(6) implanted: explanted: product type programmer, patient 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 and it was reported that the issue persisted.The caller stated this past tuesday (b)(6) 2021 they decided to open the pocket.The caller noted the connection to the ins was intermittent even when ins was out of the pocket.The healthcare provider stated he wanted to change out the device and had already got prior-authorization for it.The ins was replaced.The caller is going to send the product back in.

Event Description

Additional information was received: it was reported, the physician felt the depletion was normal.And was going to be replaced with an intellis device.

Manufacturer Narrative

Concomitant medical products: product id: 97755,serial#: (b)(6), product type: recharger, product id: 97745, serial#: (b)(6), product type: programmer patient.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.

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.

Manufacturer Narrative

Product analysis #704511918:analysis information -- 03/15/2022 10:53:59 cst pli# 20 product id# 97715 below is unedited, system generated text based on the analysis finding code(s).The returned device 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.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: 12258885
• MDR Text Key: 264494431
• Report Number: 3004209178-2021-11725
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/15/2022
• Date Device Manufactured: 02/09/2018
• 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 Age: 49 YR
• Patient Sex: Female