MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)

Event Date 09/05/2020

Event Type  Injury  

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 manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor therapy.The rep reported that they had interrogated both of the patient's devices today and the left ins provided a message back : "serial number (b)(4) system error.Therapy may have stopped.The therapy device may need to be replaced." technical services did not have information to provide rep today regarding this message.Technical services reviewed that likely a por happened or device has reached end of service (eos) and needs to be replaced.Rep indicated that the healthcare professional (hcp) had checked patient's device 2 weeks ago and got the same message.The patient is getting return of symptoms.Patient stated that they noticed stimulation had stopped on the left side.Patient also reported that about 2 months ago, she was found unconscious and then 4 days in icu.It is unknown if any defibrillation was used or any other medical procedures that could have affected the device.Technical services reviewed it may be possible it just reached eos, but suspect a different screen in the clinician app would have shown.

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.

Event Description

Additional information was received from a health care professional (hcp) via a manufacturer representative (rep).It was reported that the cause to the lack of stimulation on the left ins was undetermined.The physician interrogated the device and will be replacing it.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10817058
• MDR Text Key: 215529386
• Report Number: 3004209178-2020-19668
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR