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

Model Number 97725

Device Problems Break (1069); High impedance (1291); Unable to Obtain Readings (1516); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 977a260, product type lead.

Event Description

Information was received from a manufacturing representative (rep) regarding a trial patient with a wireless external neurostimulator (wens) for an unknown indication for use.Assistance was requested with an intra-operative procedure.It was reported that this was a trial case with the new wireless external neurostimulator (wen) and the doctor was having a ¿tough time¿ with the lead.It was reported that the doctor was trying to back out of the needle when they were trying to insert the lead into the epidural space.The rep stated that they were concerned about possible damage to the ¿wire¿.It was reported that the lead was connected to the wens and found that a full impedance check showed all red x¿s for the contacts.Technical services encouraged the rep to double/triple check to make sure the lead connections were sound, as it would take considerable damage to the lead for all the contacts to show as x¿s.There were no symptoms reported.The event occurred on (b)(6) 2018.The rep call back shortly after their initial call to ask if the leads could be tested when the lead tips were outside of conductive solution or fluid and what values would be expected.It was indicated that when they tried to test the leads when connected to a wens and an mltc when they were not implanted they got values of greater than 40,000 ohms.Technical services reviewed information about impedances.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative on (b)(4) 2018 reporting that the cause of the impedance issue was ¿purely user error.¿ it was reported that the manufacturer representative forgot to have the technician put the leads in a conductive solution when they were checking lead impedances on the back table and the electrodes were exposed to air during the testing.After the leads were implanted, the impedances were all within normal limits.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care provider (hcp) via a manufacturer representative on 2018-feb-06 reporting that when the hcp pulled the lead back from the epidural space they reported that the tip seemed to have some trouble coming through the tip of the needle.The hcp wanted the manufacturer representative to check impedances.Then all connections showed >40000.It was realized that in the rush to check the leads, the manufacturer representative forgot to have the technician put the electrodes in the back table saline solution to allow the contacts to conduct for the check.There was not a separate cause for the issue using the needle during insertion.It was confirmed that the leads worked just fine during the trial and the patient had good relief.It was noted that the patient planned to go on to implant.No further complications were reported.

• 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: 7184647
• MDR Text Key: 97482866
• Report Number: 3007566237-2018-00146
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• 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?: No
• Date Manufacturer Received: 02/06/2018
• 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