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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Charging Problem (2892); Loss of Data (2903)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Manufacturer Narrative
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
2022-oct-25 (b)(4): information was received from a patient who was implanted with an implantable neurostimulator (ins) for fbss leg/back and spinal pain indications.The reason for call was pt reported he is having trouble with recharging and how often he has to recharge his ins battery compared to his last device.Pt stated with is original implant he could go about 8 days between charges.Pt stated as the first battery aged his recharge frequency went to 4 days and he was getting messages to replace the battery - pt verified he had his ins replaced due to normal battery depletion.Pt stated the ins new battery started out needing to be charged every 4 days but now he is charging every day since in the past 2 weeks - pt stated that he has not made any changes to his programming.Pt mentioned he has had his ins programmed 1 time since implant.Pt stated one of the groups has disappeared so he wants to get programming checked pt would like to have a few programs to work with.Pss is sending a message to the local field reps about pt call.The patient was redirected to their hcp.No symptoms were reported. pt called back and patient services (ps) agent had extreme difficulty understanding pt due to connection issues.Pt said technicians; need help with stim for they lost programs; need adjustment.Pt said they needed to meet with rep in person.
 
Event Description
Additional information received from the patient.It was reported the circumstances that led to the losing of programs was the patient had not been keeping up with charging of their device.It would occasionally warn them to recharge to avoid having to reset by a technician.The patient made an appointment with their hcp who redid their programs and they had been taking care to keep their device recharged.The patient stated their device was from 2012 and seemed to be depleting more frequently.The patient noted their original battery was replaced in 2020 and needed to be recharged every 3 days.
 
Manufacturer Narrative
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.
 
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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 Key15812129
MDR Text Key308000256
Report Number3004209178-2022-15168
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2023
Date Device Manufactured08/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age79 YR
Patient SexMale
Patient Weight57 KG
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