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

Model Number 3058

Device Problem Failure to Deliver Energy (1211)

Patient Problems Swelling (2091); Therapeutic Effects, Unexpected (2099); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 10/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and hcp and a manufacturer's representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient said that the implant received on (b)(6) 2020 was a fail, and they had a revision/replacement on (b)(6) 2020.Patient said that they waited a couple of days for the swelling to go down and when they adjusted on (b)(6), they didn't feel any stimulation even at the higher settings.Patient called hcp (healthcare professional) on (b)(6) 2020 and saw hcp on (b)(6) 2020 and brought all of their equipment.Patient said that hcp checked the device and adjusted, and patient didn't feel any stimulation at all, and at that point hcp said that it was a fail and scheduled revision/replacement and scheduled x-ray.Patient said that the x-ray didn't show much change.Patient said that they called and spoke to the manufacturer¿s rep and requested for rep to be present for the revision as the rep was present for the trial.Patient said that hcp placed new wire on left side and removed the one on the right side and opened the ins pocket to insert the new lead.Patient was told that the part that plugged into the battery didn't make a connection.Patient had revision on (b)(6) 2020.The patient's relevant medical history included patient said is a spinal cord injury patient.The rep clarified they were not sure there was a failure, patient has motor response that the physician was very happy with no sensation but hcp attributes that to patient's previous procedures involving a different product, not from this manufacturer.The rep explained that nothing was removed or replaced.Everything was checked in the or, impendence and motor response were working as intended.On (b)(6) 2020 the rep explained that the hcp (healthcare professional) opened up the pocket on (b)(6) 2020 due to the patient's in office complaints.Hcp checked the device connection and rep/hcp checked impedances and patient was getting a great motor response.Last the rep heard from the patient everything was working fine after trying a couple different programs.No product was changed out, all original equipment was in place.

Event Description

Additional information was received from a healthcare professional (hcp).The hcp reported that there was no failure noted.The patient is routinely seen and good motor response was noted.

Manufacturer Narrative

H6 codes 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.

• 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: 10755272
• MDR Text Key: 213671210
• Report Number: 3004209178-2020-18919
• 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,consum
• 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: 08/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 54