MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Dizziness (2194); Insufficient Information (4580)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor therapy.It was reported that since end of august/early september the ins has not been working and wants to have it removed.Caller stated no longer feels stim.If she stops to think about her device/therapy she gets dizzy so she hasn't done anything about it.Patient services offered to check ins status with the patient using the patient programmer and caller declined.

Manufacturer Narrative

H6: due to imdrf harmonization, some previously submitted device, patient, method, result, and conclusion codes related to this event may have been updated.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

Additional information was received from the patient.They reported that they contacted the manufacturer because they received a voicemail message to return the call.The message stated for them to turn in the device.They called the number and no one there knew what they were talking about.The device had quit working, but at the time they received the voicemail, it worked.The person they spoke to when they got the manufacturer's phone number did not know what the patient was talking about either, but they were told then that the device only worked for five to seven years.They were not aware of that when it was implanted and now they wanted it removed.They planned to contact their doctor.They stated they would not have another implant from the manufacturer.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10840094
• MDR Text Key: 216385060
• Report Number: 3004209178-2020-19995
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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: 02/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR