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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Pocket Erosion (2013); Injury (2348); Fluid Discharge (2686)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Date is approximate.Other applicable components are: product id: 3889-28, lot#: va1gf35, implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 21-apr-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for fecal incontinence and ga strointestinal/pelvic floor.The patient reported their stimulator was working its way out of their body so they had a revision surgery on (b)(6) 2019.They said they learned their implant was working its way out of the body, they had seen some yellowish brown discharge in their underwear and their friends said they could see some exposed wires near their implant site.The patient said that after their revision surgery they had bandages over the implant site, but they had noticed they had a new hole the size of a quarter and they could see the wires through the hole in their body.They said they saw their physician's assistant 2x after the revision surgery and they were given antibiotics called levaquin, but they had not seen their doctor or any doctor since the revision because their doctor had left the practice.They were looking for a new healthcare provider to treat their wound.The patient was sent physician listings.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.The patient stated they had a revision on (b)(6).They reported the device was still in their lower back, the open area was painful and they were concerned about infection.

Event Description

Additional information was received from the patient.They reported that they had to have their stimulator removed twice.Their first ins was removed and they had put in a new ins.It was opening the skin and working its way out.The healthcare provider had put it right at the waist line where their belt and pants hit.It started to work its way out maybe three or four months into having the device.Troubleshooting was unable to be performed because the device had already been removed.

Manufacturer Narrative

Event date is approximate (year valid).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: 8799433
• MDR Text Key: 151338180
• Report Number: 3004209178-2019-13721
• 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: 09/15/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 09/11/2020
• Supplement Dates FDA Received: 08/27/2019; 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 79