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

Model Number 3058

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Incontinence (1928); Tingling (2171); Therapeutic Response, Decreased (2271); Electric Shock (2554); Paresthesia (4421)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Date is approximate with month/year validity.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The hcp had called for troubleshooting in syncing the 3037 and 8840 as they were having difficulty syncing.When the caller came on the line, they had just rebooted the 8840 and upon attempting to sync with the 3037, they were successful and they entered the programming session.It was also noted that the patient mentioned feeling a ¿tingle¿ when the 8840 synced with the 3037.Then the hcp started providing other information: the caller ran the therapy measurement and electrode impedance and provided the following information: program 1 - 1087 ohms, 18-33% capacity, 11-21 months remaining, program 3 - 1450 ohms, 20-36 months remaining, program 4 - over 4k ohms, 20-26 months remaining.0-3 pair over, 4k ohms, 1-3 pair over 4k ohms 2-3 pair is 1829 ohms and 0-1 pair is 1450 ohms.The patient mentioned feeling a ¿major bolt of energy ,¿ when impedances were checked.The patient stated they only used program 1 and 2 and that they¿ve noticed that the device was getting ¿finicky,¿ when asked, the patient clarified that this meant they had to increase the amplitude and/or change programs.The patient stated that they¿ve noticed that they¿ve had to increase amplitude since april and that they were using program 2 and switched to program 1 in june but that didn¿t seem to be helping so they switched back to program 2 and they had just increased the amplitude.The caller stated that program 2 was programmed to c-1.The patient inquired if their lead had to be replaced with the next ins replacement? technical services reviewed to avoid using electrodes that were over 4k ohms and to have the patient monitor their patient programmer for the low ins icon.Technical services also reviewed that the lead didn¿t need to be replaced just based on age and that they would recommend replacement if they were many impedance issues or therapy issues.The caller later called back and brought the managing hcp on the line.It was noted that initially the caller informed the managing what had occurred in the first call.It was reported that the patient had a return of incontinence symptoms in april and that before that the patient¿s impedances were all within range.The managing hcp noted that there was no specific event that led to change in the impedance.Technical services reviewed that it would be highly unlikely that impedances would jump out of range without a specific event.The managing hcp stated that the lead may have moved so they were going to pursue some imaging.In april, they adjusted amplitude but when that was not effective, they went back to the initial settings in june.It was noted the patient uses program 1 and 2 but not 3 or 4.The longevity on program 1 was 11-21 months and program 2 was 13-23 months.It was noted that the hcp was considering replacing the system and technical services reviewed mri considerations for the new lead/ins.Technical services reviewed that before a revision, the hcp could try to use different programming (ie 0/1/2) that was not currently being used on program 1 and program 2.No further complications were reported at this time.

Event Description

Additional information was received from a healthcare professional (hcp).The hcp reported that the ins and lead were explanted.

Manufacturer Narrative

H3: the implantable neurostimulator (ins) passed functional testing; however a lead or lead parts were observed inside the implantable n eurostimulator (ins) connector port.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 10480536
• MDR Text Key: 205353117
• Report Number: 3004209178-2020-15189
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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: 10/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male