MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97725

Device Problems Bent (1059); Failure to Deliver Energy (1211); High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 977a260, serial# (b)(4), product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 07-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) regarding a patient with an implantable neurostimulator for an unknown indication for use.It was reported that the doctor had placed the lead and while attempting to test it the rep did an impedance check.Electrodes 0, 3, 7 showed high impedances while the others were in the 5 to 7 thousand range.It was reported that it repeatedly had an oor when they were trying to test it and the patient did not feel paraesthesia at any point no matter what electrodes, pulse width or hz was used.It was indicated that the physician did use air for their loss of resistance so they waited about 15 minutes to see if the issue would dissipate, but the impedances stayed the same.The doctor manipulated the lead and took it in and out of the wens.It was reported that the connections were good, but the impedances were worse.The doctor pulled the lead out and felt like maybe it had a small kink at the tip and mutually agreed to just try a new wire.After the new lead was placed, impedances were in the 1000 range and the patient felt paraesthesia.The issue was resolved at the time of the report.It was reported that there were no external factors that contributed to the issue.It was reported that the rep was wondering if a large amount of epidural fat was the cause of the high and intermittent impedances.The physician and the rep both thought it was a good idea to send the lead in to see if there were any issues with it.It was reported that no symptoms were reported.The lead was never implanted and would be returned for analysis.It was reported that the event occurred on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: neu_stylet_acc, serial# unknown, product type: accessory; product id: 977a260, serial# (b)(4), product type: lead.Analysis of the lead found no issue.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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7467015
• MDR Text Key: 106713586
• Report Number: 3007566237-2018-01262
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR