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

Model Number 97725

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial#: (b)(4), product type: screening device.Product id: 977d260, serial#: (b)(4), product type: screening device.Product id: 97725, serial#: (b)(4), product type: external neurostimulator.Product id: 977d260, serial#: (b)(4), product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 13-may-2023, udi#: (b)(4) ; product id: 977d260, serial/lot #: (b)(4), ubd: 13-may-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a trial patient with a wireless external neurostimulator (wens).The rep reported that they were currently in the operating room for a trial procedure.The rep noted that she had already swapped out the wens.The rep reported that the lead went in fine, nothing unusual.The rep reported that the lead connectivity was out of range.The rep reported that 0-7 showed 40,000 ohms; 8-11 show 7,500 ¿ 11,000 ohms; 13-15 showed 40,000 ohms.The rep changed the reference electrode to 9 and the results were as follows: 8: 7360 ohms 10: 8910 ohms.The rep reported that the patient currently had general anesthesia and couldn¿t stimulate the patient for sensation.The rep reported that the physician had currently wiped the lead several times and continued to show the same impedance reading.Additional information received from a manufacturer representative (rep).It was reported that the leads wouldn't connect to the wens.A different wens was used with the same results.The leads were removed and replaced.The issue was reported to be resolved.The leads were expected to be returned for analysis.Additional information was received from a manufacturer¿s representative 9rep).The rep reported that there wasn¿t high impedance, couldn¿t get the leads to connect to the wens.The rep reported that the leads were removed and 2 new trial leads were used.The rep reported that the new leads were good and there were no issues with the new leads.No further complications 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9317422
• MDR Text Key: 173033279
• Report Number: 3007566237-2019-02349
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• 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: Other
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Date Device Manufactured: 01/14/2019
• 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