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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problems Micturition Urgency (1871); Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Twitching (2172); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate (month and year valid).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 gastrointestinal/pelvic floor therapy.They reported they had surgery on (b)(6) 2020 and had botox to the bladder.They had it turned off for the procedure, and turned it back on after.For a couple of days, it had worked ok, but then started shutting off by itself.The patient would turn it back on and after a while it would shut off by itself.When it was on, it would send some sharp shocks through and curl their toes under.The issues started a couple of days after the surgery.It was checked and verified the patient was using the programmer correctly and was not shutting off the device.They were using the power button on the front, not the left side of the patient programmer.They knew stimulation was off because when they checked the status with the patient programmer, the lightning bolt was missing.The issue was not resolved through troubleshooting, and they were redirected to follow up with a healthcare provider.

Event Description

Additional information was received from the patient.It was reported that the  patient had a bladder procedure - botox on 2020(b)(6) and said that stimulation was turned off beforehand.Patient said that the procedure was performed by doctor in boston that also works with interstim implants.Patient said she turned stimulation back on afterwards and started to notice a couple days later that the stimulation would turn off by itself.Patient said that she did check therapy status with patient programmer which confirmed that stimulation was off.Patient said that the stimulation would stay on for only minutes to the most of two hours at a time.Patient said that she also started noticing a return of symptoms: oab and pain, said received implant for ic.Patient also said that after turning stimulation on after the botox procedure patient noticed toes of her right foot curling under.Patient said that lead is placed on her right side.Patient said that rep walked her through several different troubleshooting however couldn't resolve and was redirected to consult with hcp.During call, patient connected to implant by pressing the sync key, said stimulation was off so she turned it on.Reviewed icons and patient stated does see a third icon on top row, reviewed low ins battery icon.Patient had consult with new hcp, and was told that neurostimulator battery may be getting low and could schedule a replacement however that wouldn't happen until at least either (b)(6) 2021.Patient said during appointment device was not checked.The patient was redi rected to their healthcare provider to further address the issue.  no further complications were reported/anticipated at this time.

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 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: 10622568
• MDR Text Key: 209977225
• Report Number: 3004209178-2020-17165
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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: 11/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR