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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Device Contamination with Chemical or Other Material (2944); Human-Device Interface Problem (2949); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product type: implantable neurostimulator, product id: 3889-28, lot#: va1rh1c, implanted: (b)(6) 2018, explanted: (b)(6) 2019.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 18-may-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the caller was at a case where patient was scheduled for a lead revision and was going to keep the ins.Patient was not feeling stimulation in her sacral area and report feeling stimulation in her cheeks.Caller reports that when patient was in the operating room and they were testing the impedance with the ins, impedance did not clear therefore the physician decided to implant a new ins.No further complications were reported.

Manufacturer Narrative

Product id 3889-28, lot# va1rh1c, implanted: (b)(6) 2018, explanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep) indicating that no determination was made as to why the patient was feeling stimulation in their leg.S3 responses were elicited while testing the lead intraoperatively.When asked for the cause of the impedance issues seen when testing during the procedure the rep indicated blood was seen inside of the existing battery header which kept the impedances from being within range.No further complications were reported.

Manufacturer Narrative

Product id 3889-28, lot# va1rh1c, implanted: (b)(6) 2018, explanted: (b)(6) 2019.Product type lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product type: implantable neurostimulator, product id: 3889-28, lot# va1rh1c, implanted: (b)(6) 2018, explanted: (b)(6) 2019.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 18-may-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep): the rep/hcp had previously indicated there was blood in the ins header causing the out of range impedance and was asked to clarify what led to the blood being present in the ins header.The rep replied that there was no issue with the header noted, however when the lead was pulled out of the header after set screw was loosened, blood was inside if the header.The hcp attempted to suction out the material from the inside but we were unable to get impedances to clear following that attempt as well.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id 3889-28 lot# va1rh1c implanted: (b)(6) 2018 explanted: (b)(6) 2019 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.The caller stated their ins needed to be replaced because their leads were dislodged and poking out of their skin.They stated that since the ins was implanted, it was always poking out of the skin, so their healthcare provider was going to just push it in a little further at revision/replacement surgery.When the healthcare provider was doing the surgery it was noticed that something was wrong with the battery so they replaced the entire system and switched the location to the other side of the body.The caller also mentioned that the original reason for revision/replacement was because their leads dislodged from the desired location about 6 months after implant.This caused the patient pain and no symptom control.The mentioned they did not have any falls/trauma so they did not know the reason for the issues.No further complications were reported or anticipated.

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: 9540941
• MDR Text Key: 181545331
• Report Number: 3004209178-2020-00077
• 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,Followup,Followup,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention