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

Model Number	97725
Medical Device Problem Codes	Mechanical Problem (1384); Energy Output Problem (1431)
Health Effect - Clinical Codes	Fall (1848); Device Overstimulation of Tissue (1991); Pain (1994); Hip Fracture (2349); Electric Shock (2554)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a manufacture representative (rep) and consumer regarding a patient's implantable neurostimulator (ins).It was reported from the rep stating they were on the phone with the patient and coached them through changing group on the patient controller.They were trying to have them turn the stimulation off then lower ma before changing to the next group because they told the rep that the settings from day before on group a were too strong as the day progressed.After multiple attempts to press the white on/off button on top of the controller, they were unable to press the button to get the screen to turn off.They practiced this step several times the day before in pacu (post-anethesia care unit) and it was a little difficult to them due to age, strength, and dexterity.The patient was warned that they will likely have to decrease as soon as switching to group c and to make sure they were sitting down.When they changed, the patient got extreme shock and started turning down, but they fell to the floor before they could get low enough.The rep spoke to the patient the next day and the patient reported their leg and groin hurt and they were going to urgent care or emergency room to get checked.They were diagnosed with a fractured art hip.No further complications reported/anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the healthcare professional (hcp) via a rep and it was reported that there was no device issue.Patient's group c ma was set appropriately at the facility.When the patient switched to it a home, the stimulation felt stronger.No further complications reported/anticipated.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9849074
• Report Number: 3007566237-2020-00319
• Device Sequence Number: 2856146
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 73