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

Model Number 97715

Device Problem Failure to Deliver Energy (1211)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pt (patient) reported to a manufacturer representative (rep) that the ins (implantable neurostimulator) has been turning off for little over a month now.Today's history: patient charged ins last night to 100%, stim was on.This morning patient saw ins was off.Pt manually turned stim back on, charged ins to 100% (from 75% per patient).Left at 8am with stim on and drove to appt today.Once patient arrived at clinic device was off again.Pt is currently on dtm programming, utilizing group a78% of the time and group c 22% of the time.Rep provided the following charging session info.(b)(6) 2021: 60% to 70%, (b)(6) 2021: 0% to 100% 1.5 hr; (b)(6) 2021: 10-100% 1 hr; (b)(6) 2021: 10-100% 1.2 hr; (b)(6) /2021: 10-100% 56 min; (b)(6) 2021: 30-90% 54 min; (b)(6) 2021: 10-100%1.7 hr, (b)(6) 2021: 100% 0 min.Avg charge session: 49 min.Avg days: 3 days.Additional information was received from the patient and it was reported that pt added they had a return of pain symptoms about a month ago "around may 10th".Pt mentioned seeing the hcp last week and was told to track all the days the stimulator was charged but showed as off.Agent advised pt to monitor the stimulator battery levels and to have pt potentially call into patient services when the controller displays stimulation is off to confirm that is what the controller is indicating because pt's description was unclear.The implantable neurostimulator was replaced on (b)(6) 2021 as the stimulation was shutting off sporadically.

Event Description

Additional information was received from the manufacturer representative (rep).Rep reported patient weight.

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

H3:the implantable neurostimulator (ins) passed functional testing; no significant anomalies were identified.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: 12389467
• MDR Text Key: 268991414
• Report Number: 3004209178-2021-13112
• 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
• Report Date: 06/02/2022

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: 10/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/08/2021; 06/01/2022
• Supplement Dates FDA Received: 09/23/2021; 06/02/2022
• Date Device Manufactured: 10/21/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG