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

Model Number 97715

Device Problem Energy Output Problem (1431)

Patient Problems Device Overstimulation of Tissue (1991); Discomfort (2330)

Event Date 10/13/2021

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 who was implanted with an implantable neurostimulator (ins) for spinal pain.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was to report a therapy issue.Pt stated that they went on a road trip, and forgot to bring their controller (97745).Pt stated that they are returning home to their house today, and are sure they left the controller at their house, but wanted to know if patient services could remotely shut the ins off.Pt reported that the ins is in "high gear", and explained the stimulation is so uncomfortable, they can hardly move their body.Pt stated the issue started about 1h ago (date valid), and they do not know what is causing the therapy to be so uncomfortable.Pt noted they are feeling uncomfortable stimulation in their legs, arms, and hand.Pt stated that they want to know if patient services has an "emergency setup" to shut the ins off.Troubleshooting was unable to be performed as the pt didn't have their controller.Reviewed role of ps and the controller would be needed to shut the ins off.Reviewed how to turn the ins off and to follow-up w/ the managing hcp if the issue didn't resolve.The patient was redirected to their healthcare provider to further address the issue.Reviewed how to turn the ins off w/ the controller.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12674698
• MDR Text Key: 277714440
• Report Number: 3004209178-2021-15704
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Date Device Manufactured: 03/28/2020
• 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: 57 YR