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

Model Number 97715

Device Problems Disconnection (1171); Energy Output Problem (1431)

Patient Problems Headache (1880); Malaise (2359); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 01/01/2021

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 (pt) regarding an implantable neurostimulator (ins).The reason for call was starting about 3 weeks ago or more the pt noticed that their stimulation was not working on their right side.Pt stated that they have received bad headaches that are "killing" them, making them sick and they have a hard time thinking because of the lack of therapy. the caller was redirected to their manufacturing representative (rep).Emailed reps regarding pt's therapy.Additional information was received from a manufacturer representative (rep).It was reported that the patient had an appointment to be seen in clinic on thursday (b)(6) 2021.Additional information was received from a manufacturer representative (rep).It was reported that the patient was reprogrammed and coverage was restored.The cause of the event was not determined.Additional information was reported that the patient had consistent headaches which started six or seven months ago (patient services specialist did not clarify year).Then, four to five months ago (pt also mentioned "a few months") pt stopped receiving therapy on right side; pt turned up therapy, but still did not get therapeutic relief.Yesterday, the pt had an appointment with health care provider (hcp) for injections to address back pain and numbness in arm related to arthritis, and hcp told pt one lead was disconnected from ins and was "floating." hcp directed pt to call a manufacturing representative (rep) to see if pt could get any therapeutic relief.The patient was redirected to their healthcare provider to further address the issue.Pt mentioned they had high blood pressure when they saw their hcp yesterday and mentioned they do not want to have surgery again.Pt also mentioned having routine adjustments with mdt rep (name, asked/unknown) shortly after implant date.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12108167
• MDR Text Key: 259689544
• Report Number: 3004209178-2021-10319
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/02/2021
• Date Device Manufactured: 09/14/2020
• 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: 71 YR