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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON Back to Search Results
Model Number 97800
Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Application Program Problem (2880)
Patient Problems Undesired Nerve Stimulation (1980); Impaired Healing (2378); Insufficient Information (4580)
Event Date 11/16/2022
Event Type  malfunction  
Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction.It was reported that they were just at the managing healthcare provider (hcp)'s office the other day and saw the pa.Patient said they had 2 spots that didn't heal.Patient said the pa increased stimulation but didn't want to increase stimulation any higher because they didn't want the patient to get shocked.Patient increased stimulation on program 1 to 9.8 and didn't feel a dull pain in their back, on program 2 the patient increased to 11.4 felt no stimulation and got a limit reached message.Patient saw an operation failed message, tapped try again and was able to continue adjusting stimulation.On program 3 patient got a max settings message at 0.8, on program 4 patient increased stimulation to 7.7 and felt stimulation in their back between their buttock, program 5 patient increased stimulation to 11.9 and felt a buzzing in the center of their back at the top of their buttock.Patient said they hadn't had any falls, trauma or change in activity.Patient said they had been very careful and have avoided heavy lifting.Patient said the device was not working all that well.Patient said their leakage and urgency had been a little better but they had also been staying away from caffeine.Patient said they were not really getting a 50% reduction in symptoms.Patient said the manufacturer representative (rep) set stimulation at 0.6 on program 1 after implant and the patient was able to feel stimulation in the correct location.The patient was redirected to their healthcare provider to further address the issue.
 
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Brand Name
INTERSTIM X
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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 Key18855590
MDR Text Key337131814
Report Number3004209178-2024-06463
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00763000484668
UDI-Public00763000484668
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2024
Device Model Number97800
Device Catalogue Number97800
Was Device Available for Evaluation? No
Date Manufacturer Received01/20/2023
Date Device Manufactured09/28/2022
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 Age73 YR
Patient SexFemale
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