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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 Problem Energy Output Problem (1431)
Patient Problems Dehydration (1807); Diarrhea (1811); Nausea (1970); Pain (1994); Vomiting (2144); Constipation (3274); Insufficient Information (4580)
Event Type  malfunction  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient called to inquire about their therapy and if it could cause constipation because they'd been having constipation on and off but it gotten more severe and they were having extreme unstoppable diarrhea, vomiting and nausea (the patient stated they currently had nausea) and their doctor told them they had a form of diverticulitis.The patient stated their managing health care provider (hcp) just saw them last month and they adjusted their therapy settings but the patient had no change and they still couldn't go.The patient stated they had been vomiting and spewing diarrhea everywhere and that they almost died and that they were completely dehydrated and they went to the hospital.The patient stated their gastro doctor gave them medicine that was like a spray they could put up their nose and which helped with the vomiting and pain and their family doctor had been giving them hydration.The patient stated their doctor did a colonoscopy and the patient had to drink that "crazy stuff" you have to take before a colonoscopy but they couldn't go after taking it.The patient stated they were miserable and they had pain in their stomach and it was like they were pregnant.The patient stated the first bowel movement they had after the colonoscopy: the stool as "normal" but it was "all solid" and it was black so their doctor did a cdc and they told the patient the cdc was absolutely normal and told the patient that they thought the patient's issues were related to the stimulation.The patient stated they haven't had a bowel movement since then.Patient services reviewed information with the patient and redirected the patient to follow up with their managing health care provider (hcp) about their concerns.Patient services reviewed with the patient they could turn the therapy off to isolate if the issue was being caused by the device/therapy or try a different setting and the patient stated they were afraid to "do anything" to make a change because when they made an adjustment in the past it had been "so painful" in their vagina, that they'd had "painful vibrations." the patient stated they were at their wits end and that they were going to continue working with their managing health care provider (hcp) about the issue and noted they might turn the therapy off for now though they knew without the therapy their bladder symptoms would be back.
 
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
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 Key18044754
MDR Text Key327045584
Report Number3004209178-2023-18772
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 10/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2023
Device Model Number97800
Device Catalogue Number97800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/03/2023
Initial Date FDA Received10/31/2023
Date Device Manufactured02/03/2022
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 SexFemale
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