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

Model Number 97800

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Incontinence (1928); Urinary Retention (2119); Discomfort (2330)

Event Date 09/15/2023

Event Type  Injury  

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.

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 patient said they have been doing exercises for physical therapy following a knee replacement.Patient said the exercises change every few days and most of the exercises involve tightening the muscles in the butt.Patient also said the last few nights when they have to get up in the middle of the night, the minute they stand up they have an accident.Patient said it hasn't happened every night.Patient said the stim sensation has not changed.On (b)(6) 2023 the patient noticed a bruise and a line at the ins site.Patient said when they reached back to touch the ins site it was real tender.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient on (b)(6) 2024.The patient called back and mentioned having knee replacement.Patient they saw their hcp yesterday who told them ins was fine.Patient stated that for the last couple of weeks something on the same side as their ins is bothering them.Patient stated they don't know if it is ins or hip joint.Patient stated they can't stand up without excruciating pain.Reviewed option for patient to turn ins off.Patient also mentioned that sometimes they get the urge to go to the bathroom and then nothing comes out.Reviewed to continue working with hcp regarding symptoms.

• 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: 18729894
• MDR Text Key: 335740916
• Report Number: 3004209178-2024-05053
• Device Sequence Number: 1
• Product Code: EZW
• 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: 02/19/2024

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 Expiration Date: 02/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/19/2024
• Date Device Manufactured: 09/07/2022
• 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: 80 YR
• Patient Sex: Female