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

Model Number 97715

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Neck Pain (2433); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2021, product type: lead.Product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 14-jul-2020, udi#: (b)(4); product id: 977a290, serial/lot #: (b)(4), ubd: 07-apr-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 (pt) regarding an implantable neurostimulator (ins).The reason for call was pt mentioned they went into healthcare provider (hcp) office "last month" (in (b)(6) 2021) for a revision on their neck ins. during the call, pt mentioned they had a revision surgery in 2020 or 2021 because they complained to their hcp about pain. pt had been having issues and neck pain at implant site of their neck ins for "awhile" (pt did not know event date).Pt said they learned from their hcp last month that they had a "dead lead." pt mentioned pt's current hcp took the ins out of the pocket and moved the ins up during revision last month.Pt mentioned the positional difference of the implant caused the pt to "charge differently" and the pt was still getting used to charging differently.Pt said they were not charging "higher" and charging higher was "difficult" because of the position of the ins.Pt mentioned they had 22 staples in body because of the revision surgery.Pt said the "hcp took out some of the lead" but had difficulty removing the lead because the lead was implanted deep inside the scar tissue.Pt later said the hcp took out both leads.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13117488
• MDR Text Key: 282958312
• Report Number: 3004209178-2021-19136
• 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: 12/30/2021

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: 12/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 01/02/2020
• 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 Sex: Female