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

Model Number 97800

Device Problems Energy Output Problem (1431); Data Problem (3196)

Patient Problems Incontinence (1928); Muscular Rigidity (1968); Pain (1994); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Date 07/28/2023

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 had been programming the stimulator up to 1.8.Two nights ago their bladder had over flowed.Everything was wet.Their panties were very wet.It had done that just two times.That is when they decided to up the stimulation.The reason for call was during the night it seemed like it was kind of shaking the patient.When they tried to go back to sleep it was like a sensation moving through their body, not like a shock.Patient wanted to know if they should bring the stimulation down to 1.6 instead of 1.8.Agent reviewed with the caller that they may have the stimulation too high.Told patient to bring it down to a comfortable level and see if the sensation goes away.When agent walked patient through checking their settings they were already down to 1.6.Patient decided they wanted to go to a different program.Agent walked caller through switching to a different program and adjusting it to a comfortable level.Told patient to monitor their symptoms for a couple days and see if the symptoms improve.Patient is seeing the doctor's nurse practitioner this week.Medical history: patient said tests have shown their bladder is pretty small.Additional information was received from the patient.The patient called back regarding stimulation issues.Patient said they are having "spill overs at night" patient said this has happened "a couple times".Patient said when they try to increase stimulation the "buzzing annoys me".Agent reviewed therapy adjustment options.Patient changed programs.When increasing stimulation patient stated they had a "hurt feeling" and it felt "very tight" and a "bit of pain".Patient decreased stimulation and decided to try a different program.Patient changed programs and said stimulation felt like a "tightness" and was a "weird feeling", but it was not uncomfortable.Patient will maintain stimulation level and continue to track symptoms.

Manufacturer Narrative

B3: date is estimated; month and year are valid.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.

• 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 Key: 17629064
• MDR Text Key: 322030668
• Report Number: 3004209178-2023-14949
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2023

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/27/2023
• Date Device Manufactured: 02/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female