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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 07/01/2018

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 patient implanted for non-malignant pain.The patient reported that their controller was displaying a ¿settings not available¿ message.The patient stated that they are unable to turn up their stimulation as a result and is not getting any pain relief.They noted that they tried changing groups, decreasing/increasing stimulation, and re-inserting the battery pack, but the issue remained unresolved.The patient mentioned that this occurred on both a and b groups on both sides.They stated that group b is useless to them because it was programmed so high that they can¿t feel stimulation unless they increase it to 10ma.Additional information received from the manufacturing representative (rep) indicated that they met with the patient on the day of the report.When the rep interrogated the patient¿s implantable neurostimulator (ins), their tablet displayed an alert that reference contacts 12, 13, and 14 may be open or shorted.When the rep ran full impedances, contact 14 was showing ¿do not use¿.The rep stated that reference 12 and 13 showed that electrodes were in the 1000 ohms range except for reference 14, which was 40,000 ohms.Reference 9 was 860 ohms, and reference 15 was 750 ohms.The rep stated that program 2 was no longer in out of range (oor) when decreasing to 10.4ma, but the oor was displayed again when increasing to 10.6ma.It was mentioned that the pulse width was switched to 1000us, 9.0ma, and the oor was displayed.The rep then changed programming to 9+, 13-, 15-, and the patient was feeling stimulation in their stomach.The rep reprogrammed 13+, 15-, and the stomach stimulation was occurring again.It was mentioned that the patient¿s stimulation was working well for the patient until sunday prior to the report.The rep stated that he patient had a 5-6-5 lead, and they were going to try and program using electrode 4.No further complications were reported or anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturing representative indicated that they gave another program for the patient to try.They indicated that the cause of the high impedances was not known, but the patient noted that they did yard work the day before and was lifting mulch bags.The patient¿s weight at the time of the event was unknown.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the 977c165 lead determined that the #12 and #14 conductors were cut in the body of the lead; consistent with explant damage.No significant anomalies were identified.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id 977c165, serial# (b)(4), implanted: (b)(6) 2018, explanted: (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 the patient had a lead revision on (b)(6) 2018.They stated that the lead was tested with a wireless external neurostimulator (wens) and the same contacts showed the same impedance issues as with the ins.The rep stated that the lead was then replaced, and all impedances were good once connected to the ¿new battery.¿ it was noted that the rep didn¿t mention that the ins was replaced.The rep will be returning the lead to the manufacturer for analysis.No further complications were reported or anticipated.

• 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
• MDR Report Key: 7663727
• MDR Text Key: 113522585
• Report Number: 3004209178-2018-15029
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR