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

Model Number 97715

Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, product type: programmer.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins).The patient reported that the stimulation would change without adjusting the settings with the controller.The patient reported that one time they woken up and the amplitude had changed to 0 without them changing the settings and they could not feel the stimulation.The patient reported that another time they were sitting, and the stimulation had "ramped" up so high and was causing severe amount of pain so they had to turned the stimulation off.It was reported that the stimulation changes and feels it mildly in the back and has to be turned up so high but that bothers them.The patient reported that while walking, the stimulation dropped suddenly to where it could not be felt, and it suddenly went up so high they could not walk or talk and it difficult to even get the unit to change.The patient reported that when it was turned on, it felt like someone was trying to restart their heart.It was reported that the stimulation it goes up on its own and feels like getting shocked.The patient reported that device has never worked and the first one worked great.The patient reported that they were having trouble with the controller because the controller will change setting by itself.

• 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: 10096150
• MDR Text Key: 192447614
• Report Number: 3004209178-2020-09280
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Date Device Manufactured: 10/23/2019
• 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: 70 YR