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); Electromagnetic Compatibility Problem (2927)

Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Urinary Retention (2119); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 06/18/2022

Event Type  Injury  

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.

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 reason for the call was to report that since saturday, they had been feeling really sick to their stomach and thought that might be related to the implant they just received on thursday.The patient wanted to decrease the setting.With instruction, they connected to the implant and decreased the setting by 0.3 ma and then decided to go back up by 0.2 ma.They were redirected to their doctor if the issue persisted."pain to monitor and again." they were redirected to contact their healthcare provider's office for medical direction.Additional information was received from the patient.Patient repeated previous event history regarding previous therapy concerns and decrease to stimulation.Patient stated they had it too high for someone who just got it implanted.The patient reported they got worse and worse as the months went on and wanted to get the device removed because it was causing pain."they stopped it from working" and turned therapy off about 2- 3 months ago and patient is in pain due to urinary retention.Patient reported they have to go in every couple weeks for "them to empty it".Ps asked patient to clarify what was being emptied and patient did not elaborate.Patient reported the retention is causing stomach pain, they cannot move around, cannot eat, and the whole house is a mess.Patient cannot urinate and have been hurting really bad.The doctor tried to get it to work before patient had surgery where he "went in with a balloon" and cleaned the patient out at the hospital.Patient reported the issues started right after their pump was filled.Patient also stated "everything with the pump has made them sick".They were told that cathing would make patient worse.Patient stated they are so tired of trying to figure it out.Patient's previous managing physician was reid graves however patient indicated she is no longer working with him.Patient stated he "doesn't know how to do it" and "tried so hard".Patient asked for assistance entering in a code however it was not clear what they were referring to.Patient declined external device instruction.Physician listings sent to patient via email.

• 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: 17701838
• MDR Text Key: 322877766
• Report Number: 3004209178-2023-15524
• 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: 09/07/2023

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 Expiration Date: 09/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• Date Device Manufactured: 03/24/2022
• 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 Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female