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

Model Number 97725

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erythema (1840); Unspecified Infection (1930); Irritation (1941); Pain (1994)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977d260, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 13-jan-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient complained of pain at the puncture site, but they chose not to call the hcp or seek attention because it was mild.At lead pull, the site looked red and irritated.The hcp told the patient to call if it worsened.Over the weekend, it worsened and the patient was admitted to the hospital with an epidural abscess that was treated with iv antibiotics.The hcp didn't believe this to be related to the products or sterilization, but rather he felt the patient's smoking and extreme temperatures (sweat) may have led to the patient developing an infection.The patient was recovering normally and being followed up with to evaluate further infection.The trial lead was discarded.The issue was said to be resolved.

• 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: 10390358
• MDR Text Key: 202412048
• Report Number: 2182207-2020-00675
• Device Sequence Number: 1
• Product Code: LGW
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention