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 Headache (1880); Vomiting (2144); Insufficient Information (4580)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported that since implant, whenever the stimulation is turned on they were experiencing severe headaches that would cause them to throw up and urinary issues as well.  the patient stated that during the trial they didn't get the headaches and would have the setting at 2.6 and could barely feel stimulation.  with the permanent implant, stimulation felt much stronger at 2.6, so the patient has to turn stimulation down but the headaches don't resolve.   they also tried the other programmed groups without resolve.  their doctor redirected them to get reprogramming from a manufacturer representative (rep).  they were redirected back to the doctor to schedule the appointment with the rep.  the patient met with a rep on (b)(6) 2021 and the rep performed reprogramming by giving the patient new settings.  the patient was told to try out the new settings; issue was not yet resolved.Additional information was received from the manufacturer representative (rep).The patient had the removed on (b)(6) 2021.

• 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: 12375154
• MDR Text Key: 268450492
• Report Number: 3004209178-2021-12999
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: 08/26/2021

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: 02/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/26/2021
• Date Device Manufactured: 03/12/2021
• 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: 45 YR