MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Swelling (2091); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

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 patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that they were not sure the unit was working.They tried to turn it up or down and after increasing they didn¿t feel anything like they typically do.The patient put new batteries in the programmer.The patient said they had lithotripsy done just six days ago for a stone and said they were really swollen.The said they have had lithotripsy done in the past with no problems.The patient said this problem started the morning of the call.Patient services asked if the patient has experienced a return of symptoms and they said they have it for the bladder and they have a few symptoms return but that was kind of normal for them.The patient was on program 3 at 3.9 volts and stimulation was on.The patient tried multiple programs and adjusted amplitude but felt nothing.They then got the low ins battery on the screen and poor communication.They would have to shut the programmer off and turn it back on in order to get it to sync.The patient was redirected to their healthcare professional.The patient¿s relevant medical history included kidney stones and lithotripsy.The patient confirmed when asked that the ins is in the same spot.

Manufacturer Narrative

Correction to g3: notify date, the date submitted in regulatory report 3004209178-2020-16146 was incorrect.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.

Manufacturer Narrative

Continuation of d10: product id 3093-33.Lot# v271759.Implanted: (b)(6) 2009.Explanted: (b)(6) 2020.Product type lead 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 about a week after their previous call they saw their managing physician and a manufacturer representative (rep).They said the rep checked their device and the patient was told that the lead had 12 breaks in it.They said they were told to get a new system so they could have a full-body mri.The had replacement surgery on (b)(6) 2021.Additional information was received from a manufacturer representative (rep).The rep reported that the patient programming was in (b)(6) 2020.Patient implant was in (b)(6) 2020 and 100% fully operational with no broken leads or impedance.The rep stated the patient's lead and ins were replaced in (b)(6) 2020 with 0 impedance.Regarding the lead broken in 12 pieces, they stated the patient must have been referring to meeting with the manufacturer clinician upon a reprogramming visit in (b)(6) 2020.An impedance check indicated impedance issues on every combination of the ins.It was also determined that the ins had reached eos so the replacement was scheduled for (b)(6) 2020.The cause of the reported issues was not determined, only determined there was impedance issue, but the lead was not broken in 12 different places.The rep noted that the replacement of the ins and lead in october was most likely attributed to the age of the previous system.Additional information was received from a manufacturer representative (rep).The rep reported that the impedance check indicated the impedance issues on every combination of the ipg, indicating the lead was no longer viable.The replacement of the device was due to impedance issues, it was noted the check was performed in (b)(6) 2020.The device had been discarded.

Manufacturer Narrative

G3: initial notify date should be 2020-sep-23 based upon new information from manufacturer representative.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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10547758
• MDR Text Key: 207358198
• Report Number: 3004209178-2020-16146
• Device Sequence Number: 1
• Product Code: EZW
• 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,Followup,Followup
• Report Date: 04/20/2021

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: 08/28/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/21/2021; 09/21/2021; 04/20/2021
• Supplement Dates FDA Received: 03/31/2021; 03/31/2021; 04/20/2021
• 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: 79