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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 Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
Patient Problem Electric Shock (2554)
Event Date 04/05/2023
Event Type  malfunction  
Manufacturer Narrative
Date is approximate.Year is confirmed valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urinary/bowel dysfunction.The reason for call was for mri.During the call the caller reported that they had an ekg about a year ago and turned the therapy off for it.After the ekg, they returned home and turned the therapy back on and since their body was not used to it, it shocked the caller and they screamed.The caller described it as putting a finger in an electric socket and they were very startled.They were able to turn it down.The caller reports that they now make sure to turn it down before turning it off.The caller also reports that while they are getting at least a 50% improvement in symptoms, they are not completely gone and they are not getting the same level of relief that they had with the trial.They have tried all of the programs at various intensities.The caller reports that they cannot leave their house before certain times of day or stay gone for too long due to this.The patient was redirected to their healthcare provider (hcp).
 
Event Description
Additional information was received, from the patient.They reported, that they lower the device to setting 1 and the turned it off.By the time they restarting it, they increased the settings to 8¿9.No problem since then.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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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 Key19177491
MDR Text Key341683240
Report Number3004209178-2024-09696
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00763000484668
UDI-Public00763000484668
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/15/2024
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 Model Number97800
Device Catalogue Number97800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/24/2024
Supplement Dates Manufacturer Received04/26/2024
Supplement Dates FDA Received05/15/2024
Date Device Manufactured02/03/2023
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 Age71 YR
Patient SexFemale
Patient Weight65 KG
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