MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems High impedance (1291); Energy Output Problem (1431); Patient Device Interaction Problem (4001)

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

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead; product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 18-mar-2025, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 18-mar-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that 0-4 of the connection leads in the 0-7 window are red connections impedance check has red on contacts 0, 2, 3, and 4.Yellow on contact 15.The remaining contacts are green.Patient is not able to increase stimulation and if he decreases settings, it will not go any higher.Patient is very active and recently was pushed into a chair. on (b)(6) 2021 reprogramming was done to try to get better coverage.On (b)(6) 2021 reprogramming was done again.There were some bad battery connections found at this appointment, but tried to program around them.This turned out to be unsuccessful.X-rays were done on (b)(6) 2021 when the patient went to er.This ct scan showed that the leads were still in good position.Issue not resolved at this time.Surgical intervention planned.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12786550
• MDR Text Key: 280581871
• Report Number: 2182207-2021-01967
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2021
• Date Device Manufactured: 03/22/2021
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 64 KG