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

Model Number 97715

Device Problems Failure to Interrogate (1332); Overheating of Device (1437); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755.Serial#: (b)(4).Product type: recharger.Other relevant device(s) are: product id: 97755, 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 a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was r eported that patient had been having trouble charging the ins for the last several months and now it wouldn't charge at all.It took hours to charge the ins.Ins went dead in 2 days.It constantly said that it was not charging or could not find the device.Patient had to reset the ptm 3-4 times when charging and when he plugged in the ptm back in it wouldn't charge the bp.Last night he was trying to charge the ins, the relay box on rtm felt so hot that he could not touch it, it burned his leg.Patient confirmed there was no mark, no injury.

Manufacturer Narrative

Continuation of d10: product id 97755 serial# (b)(6) implanted: explanted: product type recharger h3.Analysis found there was a recharge antenna failure and a no device found message.H6.Evaluation result code 3221 does not apply.Evaluation method code 4114 does not apply.Evaluation conclusion code 67 does not apply.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 11211187
• MDR Text Key: 228178798
• Report Number: 3004209178-2021-01154
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR