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

Model Number 3058

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot (b)(4), ubd: 18-jun-2018, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for bowel dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient had surgery this morning and had a new stimulator put in for their bowel.Patient was asked why and they said that the leads were not connected properly.Patient said the last time they put a rechargeable implant in and they weren't supposed to.The wires were all interconnected and they needed two doctors today for surgery one for the colon/rectal device and one for the pain management device.They said, "the device wouldn't take a charge or something".Patient got their interstim ((b)(4)) replaced today.Patient was advised to consult with doctor for more information.There were no other malfunction or complication were reported.

Manufacturer Narrative

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

Event Description

Additional information received later indicated that patient weight as (b)(6) pounds.

Event Description

Additional information was received from the patient.They reported that the caller was escalated they mentioned that they have had 10 surgeries because all of the machines they have had have either not worked, implanted wrong, defective batteries and more.Caller would not provide any additional information then disconnected the call.

Manufacturer Narrative

Continuation of d11: product id 97714 lot# serial# (b)(6) implanted: (b)(6) 2016, product type implantable neurostimulator.Product id 3889-28 lot# va0l239, implanted: (b)(6) 2014, 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.

• 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: 7392300
• MDR Text Key: 104174627
• Report Number: 3004209178-2018-06341
• 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: 10/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 06/07/2018; 10/05/2020
• Supplement Dates FDA Received: 06/14/2018; 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 83