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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead.Product id: 977a260, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 04-mar-2025, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 05-oct-2022, udi#: (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 non-malignant pain.It was reported that in (b)(6) 2020 the pt had spinal fusion surgery and during the surgery the doctor disconnected the leads.Pts pain doctor then did a revision for the leads and moved the ins battery either in february or march.Pt mentioned that they recently checked their position on their controller and it showed they were laying on their face and the pt never lays on their stomach.The patient was redirected to their healthcare provider to further address the issue.Pt mentioned they had an mri before.Redirected caller: patient's hcp.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12258706
• MDR Text Key: 264482706
• Report Number: 3004209178-2021-11720
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Date Device Manufactured: 04/17/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR