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

Model Number 97715

Device Problems Computer Software Problem (1112); Intermittent Continuity (1121); Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The consumer reported that his implant had been operating strangely the last four days, it would turn up very high above the setting suddenly.At other times the stimulation would shut down to almost nothing and then the stimulation would go back to normal on its own.The patient had to keep using the controller to decrease stimulation intensity but couldn¿t sleep because every little movement would zap him and the only comfortable position was sitting.A software problem screen was seen when the patient removed the battery pack.The patient stated the stimulation was unusable because it was so high.There were no falls recently and troubleshooting showed the patient how to turn stimulation off.The patient was directed to follow-up with their healthcare provider.Additional information from the patient stated the adaptive stimulation was enabled.The patient had no change in activity as they were sitting still.The issue was corrected by a manufacturer representative.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 10589983
• MDR Text Key: 208745565
• Report Number: 3004209178-2020-16746
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Date Device Manufactured: 05/21/2019
• 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: 76 YR
• Patient Weight: 101