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

Model Number 97715

Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); High impedance (1291); Failure to Interrogate (1332); Energy Output Problem (1431); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 03/14/2018

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 consumer and a manufacturer representative regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the manufacturer representative met with the patient on(b)(6) 2018 and was unable to recreate the out of regulation situation while the patient was in the office.The patient had been on high dose settings at one time, but they were now on low dose settings.The manufacturer representative reprogrammed the patient to get more stimulation in their toe and after programming, they interrogated the implantable neurostimulator with the patient controller two different times and did not see the out of regulation message.The manufacturer representative noted that all of the impedances were within range; however, the session report indicated that 0,1, 9, and 10 were out of range under the system status.The manufacturer representative left the patient with group a which didn¿t have contacts 0, 1, 9, or 10 active; however, the new groups b and c were utilizing contact 10 and the patient left on group c.Adaptivestim was added at the appointment.The patient controller was displaying a ¿settings not available¿ message.Every time that the patient turns the controller on, they get a ¿settings not available¿ message.The patient hits ¿ok¿ and tries to adjust to move up and gets the same screen.The patient has to go out of the group and into another group and back to the original group in order to get it to work correctly.The manufacturer representative changed the settings earlier in the day, and the patient thought that was reason that she was getting this screen.The patient controller didn¿t give this error message in the office; however, it does now that the patient is at home.There were no patient symptoms or complications reported.Additional information was received from the consumer on (b)(6) 2018 reporting that every time they turned on the patient programmer it showed the "settings not available" screen.The patient spoke with a manufacturer representative and the settings "and everything" was changed.As soon as the patient got home they turned it on and it showed the settings not available message.The patient was redirected to the health care provider (hcp) to have another appointment.No further complications were reported.Additional information was received from a manufacturer representative regarding the patient on (b)(6) 2018.It was reported that there was an intermittent out of regulation message occurring.The impedances were elevated and out of range.With electrode 8 as the reference electrode, all pairs were out of range except 10, 11, and 15 which were less than 2000 ohms.With 9 as the reference electrode, all were greater than 17 ,000 ohms.With 10 as the reference electrode, all were greater than 2000 ohms except 11 and 15.With 11 as the reference electrode, all were less than 2000 ohms.With 12 as the reference electrode, 13 was 2130 ohms, 14 was 2160 ohms, and 15 was 1800 ohms.With 13 as the reference electrode, 14 was 2210 ohms and 15 was 1880 ohms.With 14 as the reference electrode 15 was 1780 ohms.The primary lead was programmed on the right side and the patient wants stimulation in the big toe.There was fading stimulation along with the out of regulation message seen on the patient controller.There were also communication issues.There was no known activity or event that prompted this issue per the patient.When palpating the pocket, the patient no longer feels stimulation when pressed.It was discussed that 11 and 15 were the best options and that the manufacturer representative should try programming some lower values.The patient was referred to the health care provider to discuss a possible loose connection.There were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturing representative (rep) indicated that they followed up with the patient on (b)(6) 2018, and the patient will be having a lead revision done sometime in the beginning of (b)(6).The rep had no additional information.No further complications were reported or anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep) who was calling from the operating room (or) where the patient is having a revision; the rep said impedances were sporadic with movement.When testing in ins, patient is having high impedance.Rep reports they tested with wireless external neurostimulator (wens) and continues to be the same.Caller reports electrode 0, 1, and 2 are showing orange while electrode 10 is red.After re-testing with the wens, caller said electrode 0 and 1 are red, electrode 2 is orange, and electrode 10 is green.Caller confirmed the lead electrodes are lining up with metals on the wens.Caller reports when she changed the reference to reference 2, 0 and 1 were out of range.Reference 1: 0 was red and 2 was avoid.Reference 10: 0 and 1 were red and 2 was avoid.As a result of what was reported, it was suggested to replace the lead one at a time and check impedance.Rep said the patient had a past history of high impedances on both leads.During the revision, impedances were high in electrode 0, 1, 2, 10 with a good connection.The implantable neurostimulator (ins) was ruled out as the issue with the wens.Both leads were replaced and the leads will be sent back for testing.No environmental/external/patient factors are known that may have led or contributed to the issue.No diagnostics/troubleshooting were performed.The issue was not resolved at the time of the report.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product id: 97791, lot# unknown, product type: accessory; product id: 97791, lot# unknown, product type: accessory; 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (b)(4) 2018.It was reported the cause of the sporadic impedance issue was not determined and the leads were returned for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis of the lead (b)(4) determined that no anomalies were identified.The lead passed all functional testing in the laboratory.Analysis of the lead (b)(4) determined that no anomalies were identified.The lead passed all functional testing in the laboratory.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7436818
• MDR Text Key: 106248619
• Report Number: 3004209178-2018-08201
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 10/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 05/11/2018; 06/06/2018; 06/12/2018; 06/29/2018; 08/08/2018
• Supplement Dates FDA Received: 05/16/2018; 06/07/2018; 06/22/2018; 07/25/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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: 46 YR