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); Failure to Deliver Energy (1211); Delayed Charge Time (2586); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/01/2019

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 consumer regarding a patient who was implanted with a neurostimulator.It was reported that the controller was starting to act weird and it has been really bad.Sometimes, the controller jumps into a different language and the patient could not get into the menu to change it back to english.When the patient spoke to a manufacturer representative (rep), she was instructed to take the battery out and put it back in, which was able to change the language back to english.In addition, the patient reported that the implantable neurostimulator (ins) was taking longer to recharge.Also, the implant turns itself off and the programming was changing on its own.A replacement controller and recharger were sent to the patient. .

Manufacturer Narrative

Product id 97755, serial# (b)(4).Product type recharger, product id 97745, serial# (b)(4).Product type programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient reiterating that they had a problem in ¿like nov-dec¿ where the controller was doing all kinds of crazy stuff.The patient stated that it kept going into a foreign language, it was taking 3 to 6 hours to charge, and they would increase it to 4.0 but it would go to 2.2.The patient stated that they called one of the manufacturer representative (rep) who told them to reset the controller.The patient then was sent a replacement controller and recharger.The patient reported that it was taking forever to charge again, beginning within the last two weeks (2020).The patient indicated that they did not know what circumstances led to their implant turning off on its own and the programming changing on its own.No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: 9701271
• MDR Text Key: 179101534
• Report Number: 3004209178-2020-03196
• 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,Followup,Followup
• Report Date: 04/08/2020

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: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 04/08/2020
• Supplement Dates FDA Received: 03/11/2020; 04/08/2020
• Date Device Manufactured: 10/06/2018
• 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: 63 YR
• Patient Weight: 81