MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problems Computer Software Problem (1112); Failure to Power Up (1476); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993); Operating System Becomes Nonfunctional (2996)

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial# (b)(4), product type: programmer, patient.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(4), udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported controller screen displayed a software problem message.Patient stated the controller fell off her bed and now it sounded like something was broken in there.Patient noted seeing software problem before the controllers stopped charging.Patient reinserted battery, it worked but now controller would not charge.Troubleshooting resolved the reported issue.Additional information later date from patient stated controllers blank screen, it was unresponsive, it did not charge when plugged in.Patient noted before this.She had to wiggle the cord end to get the battery to charge.It was reviewed plugged controllers into ac adaptor and into an outlet.Patient plugged in without any battery, and controller still did not power up.Patient mentioned she would not able to sleep because she was hurting.A replacement controller would be sent.It was mentioned controller blank screen, it still did not come on with battery removed and plugged in, patient was getting software problem.No further complication and events were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report may has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8392637
• MDR Text Key: 138165926
• Report Number: 3004209178-2019-04560
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Date Device Manufactured: 11/09/2017
• 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 Age: 48 YR