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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 Unintended Collision (1429); Energy Output Problem (1431)
Patient Problems Micturition Urgency (1871); Incontinence (1928)
Event Date 04/06/2024
Event Type  malfunction  
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.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urinary/bowel dysfunction.It was reported that the patient had a forceful fall on saturday evening.Patient had no issues during the two week trial period and no issues after the device was implanted in their back until after they fell.Now their bladder has leaked twice and the urgency is there.Patient thinks something happened because they fell forward and tripped over their dog.Patient stated they had some urgency saturday evening after it happened and really noticed it yesterday.Sent email to the manufacturer representative (rep) to call the patient back.
 
Event Description
Additional information was received from a manufacturer representative (rep).The rep reported that the falls affect on the device was unknown but was most likely the cause of the return on symptoms.Patient is scheduled for an impedance check on 4/16/23 to determine if patient damaged the device.
 
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 Key19098066
MDR Text Key340806310
Report Number3004209178-2024-09023
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 Other
Type of Report Initial,Followup
Report Date 05/03/2024
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 04/08/2024
Initial Date FDA Received04/12/2024
Supplement Dates Manufacturer Received04/12/2024
Supplement Dates FDA Received05/03/2024
Date Device Manufactured12/06/2023
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 Age56 YR
Patient SexFemale
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