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

Model Number 97715

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 05/01/2018

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 implanted for non-malignant pain.The patient reported that the device is causing them more pain, and they need an adjustment.The patient stated that they are also having a lot of trouble with their controller, where it would shut off when charging their implantable neurostimulator (ins).They noted that the controller would reboot, and they saw the manufacturer symbol on the screen.The patient added that the controller is doing this all of the time.It was noted that the patient was not having issues with the controller at the time of the report but would continue to monitor it.They indicated that they are not getting any relief from their implant.The patient mentioned that the device gave them relief for the first 9-10 days, however, now their pain is unbearable.They stated that they had a fall on (b)(6) 2018, but x-rays were taken, which confirmed that everything was still intact.The patient added that they have been adjusted twice, but the issue remains unresolved.They noted that at times they can change ¿programs and numbers¿ and occasionally feel when lying down, but they currently have no relief.The patient stated that they tend not to remember things well because of the medication they are on.They mentioned that their pain is worse than before implant, and it is so bad to the point where they are getting sick.The patient stated that their pain is not the same as where they felt it before.They tried switching programs, but that did not help.The patient added that they cannot get up and walk to their car to drive.They stated that this has taken away their quality of life.The patient was re-directed to follow-up with their healthcare provider.No further complications were reported or anticipated.Additional information was received from the patient who reported that the controller constantly resets itself which using it or if it's plugged into the recharger.Patient reported a blank screen.The patient reported the controller was at 30% and charging.They left it on the table and it reset itself.Patient reported they had pain and zapping with no pain relief.It was reported x-rays were done but everything looked fine.The patient indicated they had stimulation off for about 10 days and as soon as they turned it back it started zapping them again.

• 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: 7852054
• MDR Text Key: 120471279
• Report Number: 3004209178-2018-20030
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2018
• Date Device Manufactured: 02/16/2018
• 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: 56 YR