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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3487a-33, lot#: unknown, product type: lead.Product id: 3487a-33, lot# :unknown.Product type: lead.Other relevant device(s) are: product id: 3487a-33, serial/lot #: unknown.Product id: 3487a-33, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient felt a slight heavier current than usual while changing position.Symptoms of chronic pain were returning slowly as the effectiveness of the stimulation was not given anymore which was a sudden change.No event occurred that contributed to the event, the patient was very fit and sporty.Troubleshooting was performed.The doctor performed a ¿radioscan¿.The scan showed that the leads moved and were not in the post-surgical positions anymore.Stimulation through other electrodes were not possible anymore.Impendences were bad, especially on electrodes 0 (40,000) and 2 (17,000-21,000).A surgical replacement of both leads was planned.The issue was not resolved at the time of this report.The patient was alive with no injury.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11685798
• MDR Text Key: 246040094
• Report Number: 2182207-2021-00648
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• 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: 36 YR