MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Other applicable components are:product id :3095, product type: extension.Product id: 3889-28, lot#: va20yy9, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3095.Product id: 3889-28, serial/lot #: (b)(4), ubd: 12-jul-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a manufacturer representative (rep) regarding a patient with an external neurostimulator (ens) for urgency frequency.The patient reported their husband was cleaning their wound the day prior and cut their wire.The therapy was off at the time of the report and the patient had reached out to the emergency room and notified their clinician's office.They were expecting a call back.It was unknown if the issue was resolved at the time of the report.Additional information received stated the patient's husband accidentally cut the wire, so they were no longer evaluating.Additional information was received from a manufacturer representative (rep).They reported that the patient's husband was changing their bandage and accidentally cut the percutaneous extension.The doctor was going to reconnect the percutaneous extension the day of the report and upon disconnecting they noticed that the sheath of the lead was not connected appropriately, part of the lead was exposed.It was noted the lead may have been pulled when the husband was removing the bandage.A new lead was placed the day of the report to resolve the issue.No further complications were reported or anticipated.

Event Description

Information was received from the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins).It was reported that during a lead revision procedure, the sheath/insulation on the lead had pulled away from the lead wires that it was covering.It was noted that the doctor stated that someone had pulled and cut wires from a stage 1 case and thought that this may be related to the reason for the lead damage.No symptoms were reported in the event.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of lead model 3889-33, lot # va20u14.Identified that the butt joint of the outer insulation was separated at the proximal end of the lead.The lead device was subjected to a series of standard tests that included but not limited to visual inspection and electrical 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.

Manufacturer Narrative

Section d11 information references the main component of the system and other applicable components are: product id 3095 lot# 720600001 product type extension.Product id 3889-28 lot# va20yy9 implanted: (b)(6) 2019 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.

Manufacturer Narrative

Correction: section d11 information references the main component of the system and other applicable components are: product id 3095, lot# 720600001, product type: extension, product id: 3889-28, lot# va20u14, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead, product id: 3889-28, lot# va20yy9, implanted: (b)(6) 2019, product type: lead, h3: device returned, analysis not yet complete.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: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas MN 11900 ; MY 11900
• MDR Report Key: 8887241
• MDR Text Key: 154102156
• Report Number: 3007566237-2019-01749
• 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,Followup
• Report Date: 11/07/2019

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 Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 07/21/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 08/13/2019; 08/13/2019; 08/02/2019; 11/06/2019
• Supplement Dates FDA Received: 08/14/2019; 08/14/2019; 08/21/2019; 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR