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

Model Number 97715

Device Problems Unintended Collision (1429); Battery Problem (2885); Charging Problem (2892)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt did not used their implant in a long time for the pt had no "problems" but now the pt is "in a lot of pain in that area" (pss understood around implant area in their back).Pt stated that they fell three times in the last two weeks because their legs started to hurt and gave out on them without any warning.Pt stated that their skin was tender around the implant area and it hurt to touch and they were unable to lay on the implant area.Pt mentioned they were unable to charge their implant for "it" has been on the charger for a couple days and the pt was thinking about having the implant removed.During the call pt attempted to charge their intellis implant, but verified that they didn't know what external pieces of equipment to use to charge the implant.Pt was attempting to charge their intellis implant with their previous model 97714 external pieces of equipment.Pss explained to pt that they had to use the model 97715 external pieces of equipment to charge their intellis implant.Pt then attempted to charge their implant and went through passive recharge; pt verified that they were charging their implant with an recharging quality of excellent and the green light on the top of the controller was flashing.The troubleshooting steps that were taken on the call resolved the issue.Pt mentioned that their controller was at 80% battery.Pt stated that they don't see a current hcp for they haven't had any problems and the hcp at boston medical possibly retired.Additional information received indicated that the patient complained of pain at the battery site and difficulty charging.A pocket revision completed.It was noted that the ins was depleted could not connect to it.Battery would not charge on the back table after 30 minutes, therefore the surgeon decided to implant a new ins and send explant for analysis.

Manufacturer Narrative

G3: corrected to 2021-07-28 in regulatory report.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 indicated that the patient complained of pain at the battery site and difficulty charging.A pocket revision completed.It was noted that the ins was depleted could not connect to it.Battery would not charge on the back table after 30 minutes, therefore the surgeon decided to implant a new ins and send explant for analysis.

Manufacturer Narrative

H3: product id: 97715, serial# (b)(6) was returned for product analysis.Analysis found that the implantable neurostimulator (ins) passed functional testing and found no significant anomalies.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
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12256161
• MDR Text Key: 264802259
• Report Number: 3004209178-2021-11704
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female