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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problems Burn(s) (1757); Pain (1994); Discomfort (2330)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745bp, serial#: unknown , product type accessory.Product id: 97745, serial#: (b)(4), product type: programmer patient.Product id: 97745, serial#: (b)(4), product type: programmer, patient.Product id: 97755, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).Analysis of the recharger (serial# (b)(4)) found the cable insulation was torn at the donut end, wires were cut and it was not able to find the ins.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that there was difficulty recharging.It was reported that the controller was 90% charged and the ins was at 70.It was reported the recharger would not connect.The patient had been trying to charge for hours and the no device found screen was seen.The patient reported seeing screen 16, 50, and the passive recharge screen with no numbers.The patient could not change recharging speed, and it was reported that the ins site was painful and tender.It was reported the recharger would get hot and the patient needed a new controller.Removing and replacing the battery did not resolve the issue and no cause was known.Additional information received stated that the issue was resolved and the initial issue occurred suddenly.It was reported the patient had no pain relief because the ins depleted and shut off.It was reported that the patient needed the device to live comfortable and the ins needs to be recharged daily.It was reported that by the time the replacement equipment arrived the patient was in extreme pain.It was reported the patient's back was painful and tender.The patient wanted a spare recharger (rtm), and it was reviewed that they would have to work with their hcp to get a spare.It was reported the rtm paddle got warm but did not burn.It was noted that the rtm wire had separated.There were no reported complications and no further complications were expected.Patient was implanted for spinal pain.Additional information was received from a friend/family member.The caller mentioned the first recharger antenna the patient had burned the patient's back because the recharger antenna was hot.

Manufacturer Narrative

Concomitant medical product: product id 97745bp lot# serial# unknown implanted: explanted: product type accessory product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Event Description

Additional information received from the patient reported a weight of 165 lbs.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12414366
• MDR Text Key: 271286788
• Report Number: 3004209178-2021-13288
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 61 YR
• Patient Weight: 75