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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the patient was having difficulty with stimulation today.Patient stated the stimulation only helped intermittently but has not recently and even with adjusting he was tired of it and wanted it explanted.Patient has an appointment to meet with hcp tomorrow to discuss.Patient stated if they decide now to explant they will set an appointment with the rep to optimized programming.Issue not resolved at this time.No further complications were reported/anticipated.2020-mar-19 additional information was received from the rep.Reps were unaware of stim not helping.It was reported that per the md, the patient has elected to have the device explanted.Explant date was not set.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the machine was hurting patient's bones so bad that they could not sleep, had a hard time walking, laying down, even sitting.Patient asked doctor if he could help with the pain.Doctor said no so patient told him to take it out, this went on for a year.After one year of pain, the hcp agreed to take it out.Patient's bones were lot better after it was out.The device was removed (b)(6) 2020.Doctors said they did not want the device.Patient had it with them.Patient provided their weight information.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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9961467
• MDR Text Key: 187692159
• Report Number: 3004209178-2020-06829
• 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,Followup
• Report Date: 05/06/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/06/2020
• Date Device Manufactured: 11/01/2018
• 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: 70 YR
• Patient Weight: 84