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

Model Number 3058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616)

Patient Problems Pain (1994); Skin Irritation (2076); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient felt jolting pain down in her hip and leg like sciatic pain.The patient reported she was very sensitive and sore where the ins was located.She first thought it was sciatica, as she previously had that on her right side, but then felt ¿little jolting things¿.The patient reported the current discomfort on the left side.After decreasing amplitude somewhat, she didn¿t feel any different.It was noted the setting was on p5 with an amplitude of 3.0.The patient reported she only got relief when she numbed it with ice.She also noted she felt it even after she took a deep breath.The issue had reportedly been going on for the past 3-4 weeks.The patient¿s regular doctor gave her muscle relaxers, but she did not get relief from them.Her doctor also told her she did not have any fat and her ins stuck out.The patient confirmed they had no falls or traumas.Therapy was turned off, and they planned to monitor pain symptoms to see if they would subside.Four days after the initial report, the patient called back and stated she had turned stimulation off and was still in terrible pain at the implant site.They reported soreness and she could not touch it.The patient was recommended to follow up with her healthcare provider.Two days later, the patient called back and stated the pain had not quit.She noted when she turned stim on, the pain was more intense and felt more like a jolt than pain.The patient said she changed from program 5 to program 6.They were again directed to follow-up with their healthcare provider.No further complications and no further device problems were reported.

Event Description

Additional information was received from the patient.They reported that they talked to a manufacturer representative (rep), changed to program 6, and slowly increased stimulation.They had no pain down their leg or jolts but were still sore where the device was implanted.It was noted that for now they feel good.No further patient complications were reported as a result of this event.

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.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.

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.

Event Description

Additional information was received from the patient.They reported that they were still sore, but there were still no jolts.They reiterated they had changed to program 6 from program 5 previously, and stated they remained on 1.3 volts of stimulation.No further patient complications were reported as a result of this event.

• 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: 10103319
• MDR Text Key: 193030743
• Report Number: 3004209178-2020-09411
• 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,Followup
• Report Date: 07/21/2020

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: 12/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 07/06/2020; 07/17/2020
• Supplement Dates FDA Received: 07/14/2020; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 48