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

Model Number 97715

Device Problems Electromagnetic Interference (1194); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Tingling (2171)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neuro stimulator (ins) for non-malignant pain.It was reported that patient saw "settings not available" message on the controller.Patient mentioned they had an mri today which was done within spec of unit with a 1.5 t horizontal mri for another injury unrelated to device / therapy.Patient stated during mri it was tingling all over the place even though the device was in mri mode the patient could feel it as the magnet moved up, the sensation moved with from the controller up the wiring in the patient's back.Patient then stated after he went to turn his ins back on following mri "it was not working anymore" patient clarifying he could turn settings down, but could not turn settings back up; they got "settings not available screen".Patient called the manufacturing representative (rep) who stated he could do adjustments with the clinician programmer.Patient mentioned he has turned ins off/ on several times, and turned the rate down from 1000 to 440 and the pulse down to 90.Patient mentioned he did not want to take the settings all the way down to zero in case they did not come back up.During troubleshooting it was reviewed to consider reducing intensity down to zero on active group and then increasing intensity.Patient was successfully able to turn both pulse and rate down to zero and increase as desired.Patient mentioned where his pulse rate was prior to turning to zero and increasing, he count not feel it.No further patient symptoms or complications were reported in this event.

• 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: 7352329
• MDR Text Key: 103004892
• Report Number: 3004209178-2018-05331
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018

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: 01/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 03/20/2018
• Date Device Manufactured: 01/26/2018
• 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 Age: 60 YR