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

Model Number 97715

Device Problems Energy Output Problem (1431); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/11/2019

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 manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for unknown indications.It was reported that an error message was seen on the controller screen.The patient was still able to access his programs to charge his controller.There were no reports of medical or therapy issues and no patient symptoms reported.Additional information received from a manufacturer representative (rep).It was reported that the event was resolved and the physician was notified.Additional information was received by the consumer on 2020-apr-07 reporting that the consumer had reset the controller in the past.The patient would be sitting there and feel stimulation go off.The patient would check the controller and would see error codes.The caller reported that since implant they had been having an issue with stimulation settings changing on their own.Caller states immediately after the device was implanted they had a hard time turning stimulation on and they had x-rays to check that the leads were connected correctly.Caller stated that after working on it stimulation was able to turn on.The caller believed that stimulation was turned off in (b)(6) by a manufacturer representative.Since then they has the issue where it felt like stimulation had shut off.The patient would start to feel pain and check the controller which showed stimulation was on but amplitude had gone down to xero in all the programs and groups.The consumer stated that adaptive stim was shut off (they checked the position was grayed out in the menu).No further complications were reported.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9948484
• MDR Text Key: 187206430
• Report Number: 3004209178-2020-07035
• 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: Other
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Date Device Manufactured: 03/18/2019
• 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: 49 YR