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

Model Number 97715

Device Problems Unintended Collision (1429); Energy Output Problem (1431)

Patient Problems Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, information was received from a patient regarding their implantable neurostimulator (ins).It was reported that patient's therapy may need some adjustment because he is having pain again.Pain has been really bad for the past 4 days.Patient tried to increase stimulation but if he goes higher it would just make his muscle tighten and hard for him to walk.Patient also tried the other groups but that did not help.Patient was redirected to follow up with their hcp.On 2020-june-04, additional information was received from the patient reporting that for the last six to eight months their unit was not doing them any good at all and the patient had a loss of therapeutic effect.They stated it was horrible and they wondered if they should just turn it off.It was reviewed that they had the controller and could use it how they wished.The patient stated that they had tried everything; they had turned it up and down and tried groups a, b and c and they stated that it worked best when stimulation was lower.They stated when stimulation was at.4 to.8 it didn¿t seem to agitate as much.The patient stated that when it was turned up it made their pain worse, and they stated that if they turned it off it didn¿t make much difference.The patient indicated that they had probably had about 9 to 10 falls.The event date was asked but was unknown.No further complications were reported/anticipated.

• 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: 10130230
• MDR Text Key: 195332875
• Report Number: 3004209178-2020-09903
• 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: 06/08/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/08/2020
• Date Device Manufactured: 04/15/2018
• 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 Age: 81 YR