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 Deliver Energy (1211); Overheating of Device (1437); Charging Problem (2892)

Patient Problems Burn(s) (1757); Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.Product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.It was reported that the controller isn't taking a charge when plugged in to power supply since a month ago.During troubleshooting over the phone, patient took the battery out of the controller and plugged it in to ac power and confirmed the controller powered up.Patient placed the li-battery back in the controller and stated that the green light is flashing.Patient clarified that that she met with the healthcare provider last week and was advised that the issue is with the recharger cord.The patient reported that they are unable to charge the ins and was burned by the recharger where it's placed on the skin by the coil.The patient feels like she's getting burned when trying to charge the ins.The patient stated she has a little scar on the skin from where the recharger burned her but clarified she wasn't injured and didn't seek medical attention.A replacement recharger was requested.

Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(4),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 was received and it was reported that the patient received the replacement recharger, so they recharged the ins, but they weren't feeling stimulation.They confirmed that the ins was on and there wasn't a message saying stimulation was off.The patient stated group a was highlighted in green on the home screen.They increased and decreased stimulation level on group a, but they weren't feeling the stimulation in their back or legs.The level was 0.4.The patient stated that every time they hit "a" it turned off.They were walked through switching between groups successfully.They tried group b and increased stimulation to 2.5, however it was still not doing anything.They tried group c on level 3.0 and they felt stimulation and it was working fine.

Event Description

No new information.

Manufacturer Narrative

H3: product id 97755, serial #: (b)(6) was analyzed.And it was found, that the device displayed an intermittent no device found message, the device was scrapped.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.

• 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: 10832196
• MDR Text Key: 219367241
• Report Number: 3004209178-2020-19902
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/13/2020; 01/28/2021
• Supplement Dates FDA Received: 11/25/2020; 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10"
• Patient Age: 68 YR