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

Model Number 3058

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Unspecified Infection (1930); Pain (1994); Depression (2361); Electric Shock (2554)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the caller said they need a lot of help and guidance.The patient had the system done with hopes it was going to help their bladder symptoms.The system caused severe pain.The device was going to get moved to the other side or different area.The private insurance the patient had when they first got the implant ran out so they couldn't afford insurance.Patient got on oregon state health insurance.Since the patient got the device, it has gotten more and more infected, because they didn't want to remove it under the patient's state insurance.Problem was that no one would take the patient because of the state insurance, they would just deny them.The patient has been living and suffering with it ever since.The therapy didn't work and doctor said they wouldn't do anything about it and they turned off the therapy.Problem is they left the system in and it has caused more pain.The system was electrocuting and shocking the patient.The system never did help since the day of implant.The system got infected, but caller doesn't know when it started.Caller thinks right after the patient was having trouble with it.Caller has to get records from the urologist to be able to provide better details.Caller doesn't know the actions they took for the infection.Agent asked if they have called the state insurance to see what doctor they recommend that they would cover.They said they don't have to cover the stimulator issue since patient got the implant prior to having state insurance.The issue was not resolved through troubleshooting.Troubleshooting sent the caller doctor listings in the area of where the patient lives.Agent told caller if that doesn't work out they can call back and we can see if the rep knows of any doctors not on the list in the portland area.Caller wanted to know if there was any financial assistance to get it removed.Provided caller with the patient advocate foundation phone number and web address.The patient's relevant medical history included patient is suffering from depression from the issues with the system and can't work or do anything.

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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 15534080
• MDR Text Key: 306348406
• Report Number: 3004209178-2022-12778
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Other
• Type of Report: Initial
• Report Date: 10/03/2022

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 Expiration Date: 01/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/03/2022
• Date Device Manufactured: 08/05/2013
• 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: 32 YR
• Patient Sex: Male