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

Model Number 97715

Device Problems Disconnection (1171); Failure to Deliver Energy (1211); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/25/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: (b)(4), serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Product id: (b)(4), serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: (b)(4), serial/lot #: (b)(4), ubd: 31-mar-2022, udi#: (b)(4); product id: (b)(4), serial/lot #: (b)(4), ubd: 31-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was reported that the patient said that she can't increase or decrease her stimulation, and said that she can barely feel it, it's just a slight pulse on their right side and nothing on their left side.It's usually strong, but the patient can barely feel it now.The patient said that this started just today, but they were getting really big zaps like three days before this.The patient said she has had no falls or trauma and no exposure to emi.The patient was helped with the use of their controller and it shows stimulation is on, and she is on program a, but she doesn't have any other available programs.When she presses increase on setting one it says cannot provide desired settings.When she pressed the decrease button it she was at 3.8v.No additional patient symptoms were reported.Additional information was received from the patient.The patient reported that she was still not feeling stimulation and there was no green light around the letter and she reset the controller twice.The patient tried to increase stimulation and she was getting settings not available.The patient reported that the ins was at 60% and the controller was 100% charged and she was on group a.The patient reported that after resetting the controller, there was green around group a.Additional information received from the consumer reported that the cause of the issue was the leads had been disconnected.The patient had surgery on (b)(6) 2020 to revise the issue and now it was resolved and everything was working.

• 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: 10457462
• MDR Text Key: 212360895
• Report Number: 3004209178-2020-14820
• 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: 08/26/2020

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: 02/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 08/26/2020
• Date Device Manufactured: 03/12/2018
• 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: 54 YR