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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was dissatisfied with the ins due to it not operating properly.The ins was supposed to know when he was standing up vs laying down, and it did, but when e lays down the stimulation "shocks the hell out of him" from head to toe.He did not have pain relief in his back where it was supposed to help, but if he increased stim it was felt in his legs.When the ins was turned off at night, in the morning the battery still drained like it was used all day.The patient said he tried meeting with reps, but those adjustments did not help.The ins was not charged for a week, so a no device found screen was seen.The patient did not want to charge or turn the ins back on due to what he experienced.It was mentioned that the controller said charging was excellent, but the log showed he had poor connection and it took 2.8 hours to charge to 90%.All of these issues occurred since implant.The patient was meeting with the hcp to have the device removed.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10270659
• MDR Text Key: 198731220
• Report Number: 2182207-2020-00515
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 91 YR