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

Model Number 97715

Device Problems Energy Output Problem (1431); Application Program Problem (2880); Battery Problem (2885); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  Injury  

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

The patient reported that in (b)(6) 2022 the pt started noticing a lack of pain relief.  they met with a manufacturer representative (rep) for reprogramming on (b)(6) 2022.  the rep told the pt there were two "nodes" of leads in the back that were "either blocked or there was something wrong with them".  the rep programmed around those.  the pt reported their program numbers were low like 2.8 and 3.0.  the pt stated the rep was able to get stimulation to a good point.  then the evening of (b)(6) 2022 they tried increasing stimulation but they weren't feeling it and it locked up again with settings not available.  the pt contacted the rep that evening to inform them of the settings not available message.  the pt stated they normally charged once a day at night and the next morning the device would normally be at 100%, but on the morning of (b)(6) 2022, they were surprised to find that the battery drained so fast.   patient services reviewed ins depletion is dependent on settings and usage and since the rep had reprogrammed the device, that might be the reason why.   the pt confirmed they didn't have any falls or trauma.  they had gone to their doctor for a shot the week prior to the report.  the pt was waiting to hear back from the rep.  no symptoms reported to be related to the leads.Additional information was received from the manufacturer representative (rep).It was reported that the rep clarified that two electrodes were out, not nodes.The patient had impedances.The cause of the ins draining was not determined.After consulting with tech and running a few tests it was determined that there may be a connection issue.Pt is being referred to a surgeon for a lead revision.The issue has not been resolved at this time.

• 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: 15314320
• MDR Text Key: 298856544
• Report Number: 3004209178-2022-11007
• 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
• Report Date: 08/29/2022

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: 12/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/29/2022
• Date Device Manufactured: 01/04/2021
• 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: 72 YR
• Patient Sex: Male