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

Model Number 97716

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/16/2021

Event Type  Injury  

Event Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient is non-complaint. the day after the patient's first surgery he was outside working in his yard and cutting grass.He also stated he was not charging or using the stimulator because it was not working.Patient also has difficulty saying how he is really feeling, and he was not saying that he was not getting any pain relief.The patient was not getting efficacy and after trying to reprogram the patient.Impedances and lead connections were checked at all programming sessions.The  manufacturer representative was able to get some coverage in the cervical area, but then the patient told the office that he was not getting pain relief.The office decided to get images and realized that the leads had moved down significantly out of the cervical space. the health care professional feels that the patient's non-compliance and not following post-op instructions may have caused the lead migration.  the physician decided to replace the percut aneous leads with a paddle lead which resolved the therapy issue.This replacement took place on (b)(6) 2022.

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 23-aug-2025, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 23-aug-2025, udi#: (b)(4).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
• 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: 13253425
• MDR Text Key: 283783922
• Report Number: 3004209178-2022-00607
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• UDI-Public: 00763000315474
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2022

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: 06/14/2022
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/13/2022
• Date Device Manufactured: 06/24/2021
• 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
• Patient Sex: Male