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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Electromagnetic Compatibility Problem (2927)

Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554); Insufficient Information (4580)

Event Date 03/31/2022

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 who was implanted with an implantable neurostimulator (ins).It was reported that they were implanted with a pain pump this past wednesday.Patient stated they arrived home thursday night from the hospital, got halfway in the door and it was like someone shut it (therapy) off and they could not get it to come back on (pss verified that pt was referring to their therapy stimulation).Pt said they tried other leads but could not get anything to come up.Pt said they "screwed around" with the controller half the night and finally got one lead working.Pt said they spoke to mdt rep over the phone friday.(b)(6) walked patient through getting it therapy turned back up to 1a which is the one which the patient said they use all the time.The rep advised patient to turn the stimulation up higher.Pt says they were able to get the intensity up to 10 whereas pt said they were able to then feel stimulation which was fine, but then the stimulation was going off and on all weekend.Pt added that their therapy is on 24/7; pt says they never turn the ins off.The patient was redirected to their healthcare provider to further address the issue.Pt did not allege that the pump was in any way related to the mdt device or therapy.Redirected caller: patient's hcp.

Event Description

Additional information was received from a mdt rep on april 7th.Caller was with patient at healthcare provider (hcp) office today and reiterated information about change in stim following pump implant.Caller indicated ins was turned off for pump implant but patient turned it on when they got back to their room following surgery.Patient was discharged on march 31st and that evening noticed the stim issues.Caller stated that controller confirms that ins is on even when patient notices it "cut out" or get stronger.Caller checked impedances in various positions today and everything was in range (several reference electrodes checked) around 700-1200 ohms.Caller noted that patient had been running stim around 6 ma and following pump implant, they have to increase it to around 13 ma to feel it and it has been taking longer to recharge ins (about an hour to charge from 50-100%).Caller stated stim issues subsided when patient turned ins off.Technical services (ts) had caller limit programming to each port of ins and increase stim - with contacts 5, 6 and 7 (left side) active, patient felt shocking/zapping around 11 ma.Using contacts 11, 12, 13 and 14 (right side) patient didn't feel any shocking at 10 ma.Ins is on right side, pump is in left abdomen.Ts reviewed issue may be with left tail of lead and it may have been damaged during pump implant (i.E.Cautery or tunneling).Ts reviewed that even with normal impedances, insulation of lead could have been damaged, fluid short could be occurring or some other intermittent impedance issue.Caller programmed patient using contacts 8, 9, 10 at 11.8 ma for some left side coverage and contacts 11, 12, 13, 14 around 10 ma for some right sided coverage.Ts reviewed to have patient monitor if zapping occurs now that programming has been taken off 0-7 contacts.Ts suggested imaging as well but likely if programming on 8-15 contacts isn't sufficient, they may need to consider lead replacement.Additional information was received from a mdt representative (rep) on april 13th.Impedances were checked in office on april 7th and were all within normal limits and physician is planning on getting imaging done.The cause is still unknown and the issue has not been resolved at this time.

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.

Event Description

Additional information was reported that after imaging was done.The physician did not see anything of concern on image.

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

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).It was reported that the physician opted to replace ipg.The issue has been resolved.

• 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: 14014073
• MDR Text Key: 288597292
• Report Number: 3004209178-2022-04266
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2022
• Date Device Manufactured: 04/24/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG