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 Problem (1431); Battery Problem (2885)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Discomfort (2330)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient reported that currently he was at an mri center trying to get mri of thoracic/lumbar area.Patient said last time he tried to get an mri about 3 weeks ago, he had put device into mri mode and when he was in the mri machine the stimulation "turned back on" because he could feel tingling and vibration shooting down his legs.Patient said that he knew he put the device into mri mode and when he came out of the mri machine he looked at the controller and it showed stimulator was on so he thinks he has a defective device.Patient said this time he purposely let stimulator battery go down low so it would die so that he would know the stimulator would be off for the mri mode.The patient asked how he could bypass putting device into mri mode with a low implantable neurostimulator (ins) battery.It was reviewed that ins battery needs to be greater than 20% to place into mri mode.Patient then became escal ated and said that he was fed up because the stimulator didn't work for him because it only kills about 5% of his pain.Patient said he was going to reschedule his mri, go home and charge stimulator up so that he would be able to put device into mri mode for his next mri.Patient said if the device comes on again in the mri machine he was going to have it removed.It was reviewed mri facility was welcome to invite a manufacturing representative (rep) to mri facility.Patient declined and then hung up.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10829919
• MDR Text Key: 221295496
• Report Number: 3004209178-2020-19869
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Date Device Manufactured: 02/28/2020
• 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: 54 YR