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

Model Number 3058

Device Problems High impedance (1291); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 978b128, lot# va2cxq9, implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 10-dec-2022, udi#:(b)(4), date is estimated; year is valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient did well for a short period of time, and then no longer saw symptom improvement with the device.Physician staff met with the patient and adjusted settings.The manufacturer representative did not have details on when or what was done, as the office managed all interaction with the patient.The physician scheduled the patient for a lead revision surgery.An impedance check was run on (b)(6) 2021 prior to surgery, and electrode 1 showed lead impedance >4000 ohms.During the lead revision procedure, they noticed tissue on the lead when disconnecting it from the battery, and the physician also noticed a substance inside of the battery header.They did not feel comfortable using the same ins due to this.They explanted the lead (intact) and ins, and replaced the devices.The issue was resolved at the time of the report.It was noted the patient appeared to have a high body mass index (bmi).

Manufacturer Narrative

H3: the implantable neurostimulator (ins) passed functional testing.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: 12262711
• MDR Text Key: 264765372
• Report Number: 3004209178-2021-11770
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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: 07/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR