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

Model Number 97715

Device Problem Failure to Deliver Energy (1211)

Patient Problems Headache (1880); Nausea (1970); Malaise (2359)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745bp, lot#: (b)(4).Product type accessory product id: 97745, serial#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the controller goes blank and unresponsive randomly causing the patient to have to reset the controller several times.It had been happening since 2019 implant date but it had gotten worse recently.Resetting the controller temporarily resolves the issue.It would not be connected to either power cord when it happens and the controller would have plenty of battery left.The patient confirmed the controller would power on when the battery was removed but plugged into the power supply cord/outlet and no visible damage was found.The patient wasn't feeling well but nauseous.It was reported that the patient had covid in december for 17 days and it was an extreme case.They had severe migraines, didn't eat for 2 weeks, and had a hard time remembering the time.Patient mentioned that the ins was moved from their hip back to their shoulder.They kept referring to the "device shutting off" which sometimes meant the controller itself but also explained that group b, they couldn't feel stimulation.No falls or traumas were reported.It was clarified that the patient doesn't feel stimulation on group b, doesn't like group a, so they changed to group c and left it on group c for now.

• 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: 11166771
• MDR Text Key: 234326009
• Report Number: 3004209178-2021-00716
• 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: 01/13/2021

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: 01/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/13/2021
• Date Device Manufactured: 01/29/2019
• 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: 58 YR