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

Model Number 97725

Device Problems High impedance (1291); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial#: (b)(4), product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 28-oct-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturing representative (rep) reported that there were high impedances showing in both channels during intra-op testing.They stated that there was a large amount of fluid in the epidural canal.The rep ran impedances and then switched to the opposite channel, but the issue was not resolved.The rep stated that the percutaneous trial lead was replaced with a new trial lead to resolve the issue.No symptoms were reported.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10852054
• MDR Text Key: 219174413
• Report Number: 3007566237-2020-00388
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000258115
• UDI-Public: 00763000258115
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Date Device Manufactured: 10/26/2020
• 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