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

Model Number	353101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Urinary Retention (2119); Insufficient Information (4580)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a trial patient who was using an external neurostimulator (ens) for unknown indications for non-obstructive urinary retention, fecal incontinence.The trial started on (b)(6) 2023.It was reported that patient had worsening baseline urinary retention.They had a new symptom of bowels being runny like diarrhea.On an additional call patient reported they are still not feeling the urge to urinate and they are having bouts of watery diarrhea.Patient said they were told to "play with it" and see where they feel comfortable but weren't sure what kind of adjustments should be made.Patient also mentioned that since implant, they feel like there's a bump on he left side where they have a gauze pad.Patient said it's also itchy.Reviewed general therapy guidelines, therapy optimization and expectations and stimulation sensation.Patient increased stim on the call to a comfortable level.Patient said hcp told them to wait 24 hours in between adjustments.Patient will monitor symptoms.Redirected patient to hcp about bump and itchiness mentioned.Patient mentioned they are undergoing the advanced (2 week) trial.The issue was ongoing.
Additional 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.
Event or Problem Description
Additional information was received from the patient's healthcare provider (hcp).It was reported that the steps taken to resolve the issue included will be evaluated in clinic.
Additional Manufacturer Narrative
Continuation of d10: product id 3560022.Lot# va2q57v.Product type extension.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
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin MN 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin MN 11900 ; MY 11900
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17959940
• Report Number: 2182208-2023-03093
• Device Sequence Number: 5119140
• Product Code: EZW
• UDI-Device Identifier: 00763000344573
• UDI-Public: 00763000344573
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/29/2023
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10...
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 87 KG